Data / Medical devices / United States / Boston Scientific Corporation
Boston Scientific Corporation: FDA-registered device maker in Maple Grove, MN, United States, 106 510(k) clearances and 12 PMA approvals
Boston Scientific Corporation is registered with the FDA (registration 2134265) in Maple Grove, MN, United States. It lists 46 device types. The FDA files 106 510(k) clearances and 12 PMA approvals under its listings, the newest dated August 21, 2026. 99 recall events name it as the recalling firm (12 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2134265
- FEI number
- 3002095335
- Address
- Two Scimed Place, Maple Grove, MN, United States, 55311
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 1, 2005
- Registered through
- 2027
- Brand names listed
- AGENT Paclitaxel-Coated Balloon Catheter, AngioJet Spiroflex Thrombecotmy Set, AngioJet Spiroflex VG Thrombectomy Set, AngioJet Ultra 5000A Console, AutoElite Thrombectomy System Console, ELUVIA Drug-Eluting Vascular Stent System, ENROUTE Transcarotid Stent System, Emerge PTCA Dilatation Catheter and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 106.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K253692 | AVVIGO+ Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| July 24, 2026 | K262462 | TheraSphere 360 Y-90 Management Platform | LLZ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 15, 2026 | K260771 | TruSelect 2.6 Microcatheter | KRA | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 8, 2026 | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | OBJ | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| March 20, 2025 | K250468 | iSLEEVE Introducer Set | DYB | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| October 18, 2024 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | GEH | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 10, 2024 | K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314 | LIT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 29, 2024 | K241207 | SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02) | QEW | Substantially Equivalent | Devoro Medical, Inc. | accessdata.fda.gov |
| March 13, 2024 | K234002 | ICEfx Cryoablation System (FPRCH8000-02) | GEH | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| February 1, 2024 | K240018 | WATCHMAN TruSteer Access System (M635TU90050) | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 30, 2023 | K233503 | 14F iSLEEVE Introducer Set | DYB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 22, 2023 | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | GEH | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| September 26, 2023 | K230884 | AVVIGO'+ Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 8, 2023 | K230551 | Visual-ICE Cryoablation System | GEH | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 8, 2023 | K223633 | Rubicon Control Support Catheter (H749394323506A1) | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 25, 2023 | K231176 | Stingray LP Catheter | DQY | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| April 11, 2023 | K230402 | ENROUTE® Transcarotid Neuroprotection System | NTE | Substantially Equivalent | Silk Road Medical | accessdata.fda.gov |
| September 23, 2022 | K222568 | OptiCross 18 Peripheral Imaging Catheter | OBJ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 6, 2022 | K220962 | ROTAPRO Rotational Atherectomy System | MCW | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 20, 2022 | K220866 | EKOS+ Endovascular Device | QEY | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| March 24, 2022 | K220629 | Emerge Monorail PTCA Dilatation Catheter | LOX | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| December 14, 2021 | K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | QEY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 20, 2021 | K212490 | AVVIGO Guidance System II | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 13, 2021 | K212228 | WATCHMAN FXD Curve Access System | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 25, 2021 | K210889 | iLab Polaris Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 20, 2021 | K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) | NOY | Substantially Equivalent | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | accessdata.fda.gov |
| October 2, 2020 | K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device | QEW | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 23, 2020 | K201713 | AVVIGO Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 29, 2020 | K201178 | iLab Polaris Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| April 17, 2020 | K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | ITX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 19, 2020 | K192460 | Sentinel Cerebral Protection System | PUM | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 23, 2019 | K193279 | Comet II Pressure Guidewire | DXO | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 2, 2019 | K191008 | iLab Polaris Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 5, 2019 | K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | QEY | Substantially Equivalent | Btg International, Inc. | accessdata.fda.gov |
| March 15, 2019 | K190401 | MAMBA and MAMBA Flex Microcatheters | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 26, 2018 | K182324 | EkoSonic Endovascular System | QEY | Substantially Equivalent | Btg International, Inc. | accessdata.fda.gov |
| July 30, 2018 | K181741 | IceSphere 1.5 CX Cryoablation Needle | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| May 17, 2018 | K181042 | Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter | DXK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 19, 2018 | K180102 | Embozene Color-Advanced Microspheres | NOY | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| November 21, 2017 | K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel | GEH | Substantially Equivalent | Galil Medical, Inc. | accessdata.fda.gov |
| July 25, 2017 | K171913 | Rubicon 14, 18 and 35 Support Catheters | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 24, 2017 | K170204 | FFR Link, FFR Signal Processing Module | DRG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 23, 2017 | K163314 | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter | DQY | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 24, 2017 | K162771 | EkoSonic Endovascular System with Control Unit 4.0 | QEY | Substantially Equivalent | Btg International, Inc. | accessdata.fda.gov |
| December 16, 2016 | K162373 | LC Bead LUMI | KRD | Substantially Equivalent | Biocompatibles UK Limited | accessdata.fda.gov |
| December 14, 2016 | K163174 | Emerge PTCA Dilatation Catheter | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 4, 2016 | K162350 | Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 | LIT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 12, 2016 | K162404 | Express SD Biliary Monorail Premounted Stent System | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 11, 2016 | K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX L | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| June 23, 2016 | K160823 | NC Quantum Apex PTCA Dilatation Catheter | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 26, 2016 | K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) | DXK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 11, 2015 | K152157 | LC Bead LUMI | KRD | Substantially Equivalent | Biocompatibles UK , Ltd. | accessdata.fda.gov |
| October 6, 2015 | K151613 | iLab Polaris Multi-Modality Guidance System | DQK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 22, 2015 | K152403 | Permanent Sled Bag | ITX | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| September 21, 2015 | K151313 | ZelanteDVT Thrombectomy Set | QEW | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 18, 2015 | K152316 | iLab Ultrasound Imaging System | IYO | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| August 28, 2015 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| August 27, 2014 | K133023 | JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6 | MCW | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| August 7, 2014 | K141236 | NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 7, 2014 | K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES | KRD | Substantially Equivalent | Celonova Biosciences, Inc. | accessdata.fda.gov |
| July 21, 2014 | K134031 | THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 16, 2014 | K141112 | STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| July 2, 2014 | K141485 | ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| May 21, 2014 | K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | QEY | Substantially Equivalent | Btg International, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140495 | LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 3, 2014 | K132914 | ACUITY PRO LEAD DELIVERY SYSTEM | DQY | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| March 31, 2014 | K140584 | ICEROD CX CRYOABLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| February 14, 2014 | K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET | QEW | Substantially Equivalent | Possis Medical, Inc. | accessdata.fda.gov |
| December 20, 2013 | K133566 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS | MCW | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 17, 2013 | K132430 | STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 29, 2013 | K130381 | ANGIOJET ULTRA POWER PULSE KIT | QEW | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| July 10, 2013 | K130391 | EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT | LOX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 10, 2013 | K130637 | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM | MCW | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| February 20, 2013 | K123424 | MDU5 PLUS STERILE BAG | ITX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 8, 2012 | K122795 | STINGRAY GUIDEWIRES | DQX | Substantially Equivalent | Bridgepoint Medical | accessdata.fda.gov |
| September 14, 2012 | K121694 | IMAGER II ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| September 13, 2012 | K121774 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS | MCW | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| August 31, 2012 | K121196 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | LOX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| August 28, 2012 | K121251 | ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| August 13, 2012 | K121667 | NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) | LOX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| June 6, 2012 | K113363 | ANGIOJET SOLENT DISTA THROMBECTOMY SET | QEZ | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| March 22, 2012 | K113220 | EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) | LOX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 15, 2012 | K113090 | LEVEEN SUPERSLIM NEEDLE ELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 3, 2011 | K111705 | EKOSONIC ENDOVASCULAR SYSTEM | QEY | Substantially Equivalent | Ekos Corporation | accessdata.fda.gov |
| June 21, 2011 | K110946 | ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| May 31, 2011 | K111295 | .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS | LIT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 24, 2011 | K111182 | ANGIOJET SOLENT OMNI THROMBECTOMY SET | QEZ | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| May 10, 2011 | K102725 | CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M | DQY | Substantially Equivalent | Bridge Medical, Inc. | accessdata.fda.gov |
| June 16, 2010 | K101406 | ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 | QEZ | Substantially Equivalent | Medrad Interventional/Possis | accessdata.fda.gov |
| April 16, 2010 | K094018 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | HCG | Substantially Equivalent | Biocompatibles UK Limited | accessdata.fda.gov |
| March 5, 2010 | K093969 | ACUITY BREAK-AWAY GUIDE CATHETER | DQY | Substantially Equivalent | Cardiac Pacemakers, Inc. | accessdata.fda.gov |
| December 23, 2009 | K093720 | STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO | LIT | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| December 23, 2009 | K093636 | STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX | LIT | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| December 24, 2008 | K083091 | LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES | KRD | Substantially Equivalent | Biocompatibles UK Limited | accessdata.fda.gov |
| April 4, 2008 | K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 | QEZ | Substantially Equivalent | Possis Medical, Inc. | accessdata.fda.gov |
| November 14, 2007 | K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS | QEZ | Substantially Equivalent | Possis Medical, Inc. | accessdata.fda.gov |
| April 27, 2006 | K060390 | SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| February 13, 2006 | K060144 | SEEDNET/SEEDNETGOLD, CRYOTHERA AND CRYO-HIT SYSTEMS | GEH | Substantially Equivalent | Galil Medical , Ltd. | accessdata.fda.gov |
| December 16, 2005 | K053116 | STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX | DQY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 30, 2005 | K053128 | SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE | GEI | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 10, 2026 | P130030 | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE | MAF | 75 | March 10, 2026 | accessdata.fda.gov |
| February 29, 2024 | P230035 | AGENT Paclitaxel-Coated Balloon Catheter | OOB | 8 | August 28, 2026 | accessdata.fda.gov |
| March 17, 2021 | P200029 | TheraSphere | NAW | 14 | October 13, 2026 | accessdata.fda.gov |
| October 30, 2020 | P190019 | Ranger Paclitaxel-Coated PTA Balloon Catheter | ONU | 41 | August 4, 2026 | accessdata.fda.gov |
| September 18, 2018 | P180011 | Eluvia Drug-Eluting Vascular Stent System | NIU | 67 | August 21, 2026 | accessdata.fda.gov |
| October 2, 2015 | P150003 | SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | NIQ | 109 | August 21, 2026 | accessdata.fda.gov |
| July 21, 2015 | P140028 | INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM | NIP | 86 | August 21, 2026 | accessdata.fda.gov |
| May 18, 2015 | P140026 | ENROUTE TRANSCAROTID STENT SYSTEM | NIM | 31 | January 8, 2026 | accessdata.fda.gov |
| March 13, 2015 | P130013 | WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY | NGV | 84 | August 28, 2026 | accessdata.fda.gov |
| December 11, 2008 | P060006 | BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM | NIN | 104 | December 12, 2023 | accessdata.fda.gov |
| March 12, 1999 | P980037 | ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER | MCX | 93 | August 1, 2025 | accessdata.fda.gov |
| May 28, 1993 | P900056 | ROTABLATOR(R) | MCX | 219 | October 21, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 24, 2026 | 99687 | Class I | Ongoing | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/10 | Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. | accessdata.fda.gov |
| July 9, 2026 | 99454 | Class I | Ongoing | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter | Potential for arterial sheath tip separation or partial tip separation during use. | accessdata.fda.gov |
| June 19, 2026 | 99236 | Class II | Ongoing | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revis | accessdata.fda.gov |
| May 11, 2026 | 99063 | Class II | Completed | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device | There is the potential for leakage along the drug pathway from the pump through the end of the catheter. | accessdata.fda.gov |
| December 3, 2025 | 98149 | Class II | Ongoing | Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Per | Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in cathe | accessdata.fda.gov |
| August 18, 2025 | 97466 | Class II | Ongoing | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000 | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | accessdata.fda.gov |
| August 5, 2025 | 97396 | Class II | Ongoing | Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions) | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter. | accessdata.fda.gov |
| July 29, 2025 | 97363 | Class I | Ongoing | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately thre | accessdata.fda.gov |
| July 7, 2025 | 97243 | Class I | Ongoing | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL | Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. O | accessdata.fda.gov |
| March 24, 2025 | 96556 | Class II | Ongoing | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functional | accessdata.fda.gov |
| September 5, 2024 | 95331 | Class II | Ongoing | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid | accessdata.fda.gov |
| July 18, 2024 | 95186 | Class II | Ongoing | Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail | There is the potential for holes in the clear sterile barrier of the device pouch which may impact device sterility. | accessdata.fda.gov |
| March 21, 2024 | 94240 | Class I | Ongoing | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. | accessdata.fda.gov |
| March 5, 2024 | 94162 | Class II | Ongoing | OptiCross Coronary Imaging Catheter, REF H749518080120 | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. | accessdata.fda.gov |
| February 20, 2024 | 94126 | Class I | Ongoing | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 | An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colos | accessdata.fda.gov |
| February 20, 2024 | 94041 | Class II | Ongoing | Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system | Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak. | accessdata.fda.gov |
| July 27, 2023 | 92785 | Class II | Ongoing | Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. | accessdata.fda.gov |
| April 5, 2023 | 92072 | Class II | Ongoing | WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package) | The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. | accessdata.fda.gov |
| October 13, 2022 | 90984 | Class II | Ongoing | EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System. | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. | accessdata.fda.gov |
| August 9, 2022 | 90735 | Class II | Ongoing | Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. | accessdata.fda.gov |
| May 25, 2022 | 90528 | Class II | Ongoing | EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches ar | Product may be mislabeled. | accessdata.fda.gov |
| March 8, 2022 | 89753 | Class II | Ongoing | ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy | Pouch seals may be open, compromising sterility. | accessdata.fda.gov |
| November 8, 2021 | 89034 | Class II | Terminated | Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU). | Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity. | accessdata.fda.gov |
| July 23, 2021 | 88369 | Class II | Ongoing | TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) | Potential for leaks and loosening at the patient catheter connection | accessdata.fda.gov |
| April 21, 2021 | 87839 | Class II | Terminated | ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or prox | One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging. | accessdata.fda.gov |
| April 12, 2021 | 87721 | Class I | Ongoing | VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature. | The firm has received reports of stent migration after implantation | accessdata.fda.gov |
| March 5, 2021 | 87539 | Class II | Terminated | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton. | The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. | accessdata.fda.gov |
| November 18, 2020 | 86777 | Class II | Completed | IceFORCE" 2.1 CX 90 Cryoablation Needle | Complaint trend regarding needle shaft gas leaks. | accessdata.fda.gov |
| November 17, 2020 | 86947 | Class I | Terminated | Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904 | Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system. | accessdata.fda.gov |
| February 11, 2020 | 84886 | Class I | Ongoing | Imager II 5F Angiographic Catheters, 5 units per package. | Potential for tip detachment of Imager II 5F Angiographic Catheters | accessdata.fda.gov |
| October 24, 2019 | 84152 | Class II | Terminated | Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; 2. REF/Catalog No. H7493918912200, EMERGE MR US 2 | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process. | accessdata.fda.gov |
| December 19, 2018 | 81863 | Class II | Terminated | Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous translu | A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires. | accessdata.fda.gov |
| December 11, 2017 | 80513 | Class II | Terminated | Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on t | Potential polymer material degradation. | accessdata.fda.gov |
| November 6, 2017 | 78587 | Class II | Ongoing | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatmen | Stent possibly unable to be fully released from the delivery system. | accessdata.fda.gov |
| April 5, 2017 | 76955 | Class II | Terminated | The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. Some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters. | accessdata.fda.gov |
| December 15, 2016 | 76772 | Class II | Terminated | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN) | A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user. | accessdata.fda.gov |
| December 13, 2016 | 76002 | Class II | Terminated | Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN) | One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters. | accessdata.fda.gov |
| March 28, 2016 | 73719 | Class II | Terminated | Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label),H7491490201MJo (UPN referenced on the Pouch Label). Boston Scientific PT Graphix Magnet Gui | Boston Scientific is voluntarily implementing a Medical Device Recall of one batch of PT Graphix Magnet J-TIP Guidewires. Boston Scientific has found that, while the batch is labeled as a J-tip model, the guidewires are straight and do not have the pre-formed J-tip. The most severe injury expected to occur is a limited procedure delay caused by the need to r | accessdata.fda.gov |
| March 22, 2016 | 73633 | Class I | Terminated | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary va | Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient. | accessdata.fda.gov |
| November 19, 2015 | 72702 | Class I | Terminated | Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H749392775452 | Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism of device fragments. | accessdata.fda.gov |
| October 9, 2015 | 72409 | Class I | Terminated | RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a di | Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture. | accessdata.fda.gov |
| August 25, 2015 | 72045 | Class II | Terminated | Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406), 27mm x 12F(M635WU27060, WU2706), 30mm x 12F(M635WU30060, WU3006), | Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing po | accessdata.fda.gov |
| July 31, 2015 | 71849 | Class II | Terminated | AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in | AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015. | accessdata.fda.gov |
| February 25, 2015 | 70632 | Class II | Terminated | Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Cap | Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment re | accessdata.fda.gov |
| February 25, 2015 | 70604 | Class II | Terminated | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits | Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments. | accessdata.fda.gov |
| March 3, 2014 | 67658 | Class II | Terminated | Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664. | The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy. | accessdata.fda.gov |
| February 4, 2014 | 67437 | Class II | Terminated | Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. | Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has rec | accessdata.fda.gov |
| July 31, 2013 | 65919 | Class II | Terminated | Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthe | Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to | accessdata.fda.gov |
| June 26, 2012 | 62450 | Class II | Terminated | BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are | BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem. | accessdata.fda.gov |
| March 15, 2012 | 61505 | Not yet classified | Terminated | Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. The following | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter. An investigation has found that, during shipping, some units in the 5-pack box may experience a physical interaction between the carton and the area on the pouch where the hub is located. T | accessdata.fda.gov |
| November 3, 2011 | 60365 | Not yet classified | Terminated | Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture, Japan, Distributed by Boston | Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator. | accessdata.fda.gov |
| August 1, 2011 | 59693 | Not yet classified | Terminated | Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Boston Scientific. NW 41 Street, Miami, FL 33166. Intended for the infusion of therapeutic agents (i.e., hep | Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm. | accessdata.fda.gov |
| May 25, 2011 | 59096 | Not yet classified | Terminated | Boston Scientific, WALLSTENT" Endoprosthesis & WALLSTENT" RP Endoprosthesis, Self Expanding Stent, Stent Auto-expanisvel, Made in Ireland, Ballybrit Business Park, Galway, IRELAND, STERILE, EO. Indicated for use in the t | Boston Scientific is initiating an important field correction related to WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis products. This letter is intended to clarify and re-emphasize that U.S. WALLSTENT", WALLSTENT" RP, and WALLGRAFT Tracheobronchial Endoprosthesis stents are NOT currently cleared by the FDA for use in benign tracheo | accessdata.fda.gov |
| May 19, 2011 | 58910 | Not yet classified | Terminated | Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05107. 5mm x 100 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 5 | Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the p | accessdata.fda.gov |
| March 28, 2011 | 58405 | Not yet classified | Terminated | Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Parkway, Fremont, CA 9453 | Catheter tip detachment that is not associated with elongation of the catheter typically caused by excessive pulling forces. EXPANDED: Boston Scientific is initiating a recall of all iCross Coronary Imaging Catheters because they have received and confirmed 8 occurrences of catheter tip detachments due to embrittlement. | accessdata.fda.gov |
| September 27, 2010 | 56909 | Not yet classified | Terminated | Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: | Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints. | accessdata.fda.gov |
| June 3, 2010 | 56059 | Not yet classified | Terminated | Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Valley City, UT 84119 US | Boston Scientific is initiating a Medical Device Recall regarding specific lots of the FathomTM-14 Steerable Guidewire. For lubricity, the distal portion of these guidewires is coated with hydrophilic polymer and the proximal portion is coated with polytetrafluoroethylene (PTFE). Through internal inspection process, the firm determined that Fathom guidewires | accessdata.fda.gov |
| April 19, 2010 | 55620 | Not yet classified | Terminated | Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeab | Boston Scientific Corporation is conducting a Medical Device Recall of certain lots/batches of its Back-up Meier Steerable Guidewires. Through their internal inspection process, they identified that the polytetrafluoroethylene (PTFE) coating on the gold plated distal coil of the Back-up Meier Steerable Guidewires of the identified lots/batches have the poten | accessdata.fda.gov |
| February 18, 2010 | 54669 | Not yet classified | Terminated | Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, | Boston Scientific Corporation is conducting a Medical Device Recall Removal of specific lots/batches of the Blue Max and Ultrathin Diamond Balloon Dilatation Catheters. Boston Scientific has determined that, the sterile barrier in the catheter packaging (i.e. outer pouch side seal) of the affected products may be compromised. An undetected breach in sterilit | accessdata.fda.gov |
| October 22, 2009 | 53704 | Not yet classified | Terminated | Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7,8 & 9 Annacotty Busi | The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient. | accessdata.fda.gov |
| September 29, 2009 | 53471 | Not yet classified | Terminated | Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology P | Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adver | accessdata.fda.gov |
| September 11, 2009 | 53435 | Not yet classified | Terminated | Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a | Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte Bare-Metal stent, and Libert | accessdata.fda.gov |
| August 26, 2009 | 53143 | Not yet classified | Terminated | Boston Scientific Renegade" Hi-Flo Microcatheter, Peripheral Vascular Use. Sterilized with Ethylene Oxide. Legal Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. M001 | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. | accessdata.fda.gov |
| August 17, 2009 | 53179 | Not yet classified | Terminated | Boston Scientific, Contour SE Microspheres, for tumor treatment. UPN Codes: Description: M001761101 Contour SE//1mL/2vials M001761122 Contour SE//1mL/5vials M001761141 Contour SE//2mL/2vials M001761162 Contour SE//2mL/5v | Compromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affected product is packaged within a vial. Boston Scientific has determined that, for affected products, the sterile barrier in the packaging (pouch) that contains the vial may be breac | accessdata.fda.gov |
| August 5, 2009 | 52826 | Not yet classified | Terminated | Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX. Boston Scientific Guide Catheters | Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile barrier in the packaging may be compromised. During internal inspections, they discovered gaps between the side seals and | accessdata.fda.gov |
| July 1, 2009 | 52717 | Not yet classified | Terminated | Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, | Boston Scientific is initiating a recall of a single batch/lot of this product. We received a report that the labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink insc | accessdata.fda.gov |
| May 12, 2009 | 52098 | Not yet classified | Terminated | Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures. | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of | accessdata.fda.gov |
| March 18, 2009 | 51334 | Not yet classified | Terminated | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271770 FLEXIMA NEPH FIRM 8F/25CM M001271780 FLEXIMA NEPH FIRM 10F/25CM M001271790 FLEXIMA NEPH REG 8F/25CM M001271800 | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During the attempted removal of the device, sutures were separated from the catheter and remained in the patient. | accessdata.fda.gov |
| March 11, 2009 | 51865 | Not yet classified | Terminated | Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as ballo | Boston Scientific has initiated a recall of the Wiseguide Guide Catheter. They have received reports of difficulties in connecting the product hubs with the Y-Adaptors and toughy borst connectors. If there is difficulty making such connection, there is a potential for prolongation or delay of the procedure in order to exchange the catheter or connector. Ther | accessdata.fda.gov |
| November 21, 2008 | 50487 | Not yet classified | Terminated | Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland: Interventional Technologies Europe Ltd., | For one batch/lot of flextome Cutting Balloon (OTW), an incorrect compliance chart was packaged inside the sterile pouch. For the affected batch/lot, the compliance chart packed inside the pouch of the 4.0mm diameter Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon device. This labeling discrepancy could create a procedural de | accessdata.fda.gov |
| October 7, 2008 | 50096 | Not yet classified | Terminated | Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide gas. UPN for inner pouch M001434520. Indicated for use endoscopically or percutaneously to retrieve t | Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device. | accessdata.fda.gov |
| August 25, 2008 | 49462 | Not yet classified | Terminated | Platinum Plus" LT, REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: | Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There i | accessdata.fda.gov |
| June 19, 2008 | 49001 | Not yet classified | Terminated | Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire has been | Boston Scientific is initiating a voluntary recall of the Platinum Plus Coronary Guidewire. Through our internal inspection process, we identified the potential that the PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could be damaged in certain locations. This damage of the coating creates the potential for small particles of | accessdata.fda.gov |
| June 6, 2008 | 48697 | Not yet classified | Terminated | Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300] | Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach oc | accessdata.fda.gov |
| May 20, 2008 | 49061 | Not yet classified | Terminated | Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Court, Mountain View, CA | Boston Scientific is initiating a field correction for 48 lots/batches of the Filter Wire EZ" Embolic Protection System. Boston Scientific has determined that the Directions for Use (DFU), which accompanies each packaged device, may be missing. If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another pro | accessdata.fda.gov |
| November 20, 2007 | 45903 | Not yet classified | Terminated | Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULTI PIT 124 (Single Pack) | Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure. | accessdata.fda.gov |
| September 11, 2007 | 44901 | Not yet classified | Terminated | Boston Scientific mach 1 Guide Catheter, 8F, FCL 3.5 SH Femoral Curve Left 3.5, REF 34358-268, UPN H749343582680, Sterile EO Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Rubio | Missing holes: Catheters are missing the catheter's side holes. | accessdata.fda.gov |
| December 13, 2006 | 37001 | Not yet classified | Terminated | Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja Cali | Excess strands of resin may exist in the lumen near the hub of certain batches/lots of the Mach 1 Guide Catheters. If this excess resin is present in the catheter, there is the potential of an embolization resulting from the excess resin detaching from the device during the procedure. | accessdata.fda.gov |
| December 12, 2006 | 36979 | Not yet classified | Terminated | Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents | Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly. | accessdata.fda.gov |
| October 6, 2006 | 37837 | Not yet classified | Terminated | Boston Scientific Medi-Tech Stainless Steel Greenfield Vena Cava Filter, order #50-400, lot #7826572 | One lot of product, Stainless Steel Greenfield Vena Cava Filter, may have the incorrect expiration date of 2008-07 and the correct date is 2008-06. | accessdata.fda.gov |
| August 31, 2006 | 36201 | Not yet classified | Terminated | Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires avail | The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. | accessdata.fda.gov |
| July 21, 2006 | 35939 | Not yet classified | Terminated | Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760. | Lack of assurance of sterility (pre-sterilization bioburden limits exceeded) | accessdata.fda.gov |
| May 30, 2006 | 35549 | Not yet classified | Terminated | Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scie | Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. | accessdata.fda.gov |
| May 22, 2006 | 35515 | Not yet classified | Terminated | Boston Scientific Wiseguide Guide Catheter 7F,.076 '', Femoral Approach, Manufactured for Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311. Nonpyrogenic. | Gaps were identified between polymer segments on the 7F Wiseguide Guide Catheter in which the PTFE was not properly laminated to the braid of the catheter. This delamination of the PTFE from the braid could compromise the device delivery. | accessdata.fda.gov |
| December 2, 2005 | 34134 | Not yet classified | Terminated | Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. | There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. | accessdata.fda.gov |
| August 5, 2005 | 32889 | Not yet classified | Terminated | Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Fa | Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear. | accessdata.fda.gov |
| April 19, 2005 | 31998 | Not yet classified | Terminated | PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. | Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength. | accessdata.fda.gov |
| October 29, 2004 | 30405 | Not yet classified | Terminated | RunWay 6F Cardiovascular Guide Catheter. | The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon | accessdata.fda.gov |
| July 9, 2004 | 29560 | Not yet classified | Terminated | WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. | Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use. | accessdata.fda.gov |
| July 1, 2004 | 29479 | Not yet classified | Terminated | TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part | On a few occasions the balloon has failed to deflate within one minute after deployment of the stent. | accessdata.fda.gov |
| May 24, 2004 | 32922 | Not yet classified | Terminated | Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, M | Some Mach 1 6F Coronary Guide Catheter could be mislabeled in that a few units labeled as Mach 1 6F Kimny Curve style, could contain a Mach 1 6F JR 3.5 curve style and a few units labeled as Mach 1 6F JR 3.5 curve style, could contain a Mach 1 6F Kimny curve style. | accessdata.fda.gov |
| May 14, 2004 | 32924 | Not yet classified | Terminated | Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Sten | One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package. | accessdata.fda.gov |
| February 13, 2004 | 28447 | Not yet classified | Terminated | Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 | Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain. | accessdata.fda.gov |
| August 20, 2003 | 27231 | Not yet classified | Terminated | Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011 | Some of the recalled catheters have a component that has levels of pyrogens above specification. | accessdata.fda.gov |
| August 1, 2003 | 27034 | Not yet classified | Terminated | Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter | Some of the recalled catheters may be in pouches with incomplete seals. | accessdata.fda.gov |
| July 16, 2003 | 26881 | Not yet classified | Terminated | Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 | There is an Increased potential for broken struts of the stents. | accessdata.fda.gov |
| July 1, 2003 | 26708 | Not yet classified | Terminated | Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015 | Some of the product pouches have holes in the seals. | accessdata.fda.gov |
| March 20, 2003 | 25844 | Not yet classified | Terminated | Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250 | The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility. | accessdata.fda.gov |
| March 17, 2003 | 25947 | Not yet classified | Terminated | Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 | A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification. | accessdata.fda.gov |
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Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.