Data / Medical devices / United States / Abbott Vascular
Abbott Vascular: FDA-registered device maker in Temecula, CA, United States, 91 510(k) clearances and 13 PMA approvals
Abbott Vascular is registered with the FDA (registration 2024168) in Temecula, CA, United States. It lists 32 device types. The FDA files 91 510(k) clearances and 13 PMA approvals under its listings, the newest dated April 24, 2026. 31 recall events name it as the recalling firm (5 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2024168
- Address
- 26531 Ynez RD., Temecula, CA, United States, 92591
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 1, 1988
- Registered through
- 2026
- Brand names listed
- 20/30 Indeflator, 20/30 PPAK w/COPILOT, 20/30 PPAK with Bleedback Control Valve, AMPLATZER Guidewires, Abbott Medical Epicardial Cable, Abbott Medical Patient Cable, Abbott Medical Threshold Cable, Absolute Pro 35 Biliary Self-Expanding Stent System 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| February 13, 2026 | K252512 | Armada™ 14 NC PTA Catheter | LIT | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| November 6, 2024 | K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | DQX | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 19, 2023 | K232458 | JETi™Hydrodynamic Thrombectomy System | QEZ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| September 8, 2023 | K232386 | ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| April 14, 2023 | K230411 | Dragonfly OpStar™ Imaging Catheter | DQO | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 30, 2022 | K220634 | NC TREK NEO Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| May 5, 2022 | K221057 | Viatrac 14 Plus Peripheral Dilatation Catheter | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| April 30, 2022 | K220243 | Ultiri Measurement System | DQK | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| February 1, 2022 | K213565 | JETi AIO Peripheral Thrombectomy System | QEZ | Substantially Equivalent | Walk Vascular, LLC | accessdata.fda.gov |
| June 8, 2021 | K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | NQQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| November 13, 2020 | K201881 | CoroFlow Cardiovascular System | DQK | Substantially Equivalent | Coroventis Research AB | accessdata.fda.gov |
| July 30, 2020 | K201834 | HI-TORQUE PROCEED Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| April 8, 2020 | K200144 | HI-TORQUE Steelcore Bare Guide Wire | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| December 17, 2019 | K192267 | ILUMIEN System with AptiVue Software version D.3 | DQO | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 11, 2019 | K193126 | HI-TORQUE InfilTrac Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| July 25, 2019 | K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires | NTE | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| April 2, 2019 | K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | NQQ | Substantially Equivalent | St. Jude Medical (Now Abbott Medical) | accessdata.fda.gov |
| August 24, 2018 | K180040 | NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Catheter; TREK™ RX Coronary Dilatation Catheter; TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ RX Coronary Dilatation Catheter; MINI TREK™ OTW Coronary Dilatation Catheter; MINI TREK™ II OTW Coronary Dilatation Catheter | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 28, 2018 | K180558 | PressureWire X | DXO | Substantially Equivalent | St. Jude Medical (Now Part of Abbott Medical) | accessdata.fda.gov |
| January 12, 2018 | K173795 | HI-TORQUE TurnTrac Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 25, 2017 | K172073 | Hi-Torque Command 18 Guide Wire | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| November 22, 2016 | K161873 | Pacel Flow Directed Pacing Catheter | LDF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| August 15, 2016 | K161171 | PressureWire X Guidewire | DXO | Substantially Equivalent | St. Jude Medical, Inc. | accessdata.fda.gov |
| June 29, 2016 | K160878 | OPTIS Metallic Stent Optimization E.4 SW | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| October 29, 2015 | K152120 | OPTIS Mobile System | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| October 22, 2015 | K152784 | Pacel Bipolar Pacing Catheters | LDF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 21, 2015 | K152709 | HI-TORQUE BALANCE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 5, 2015 | K151286 | OPTIS Integrated System Mobile Workstation | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| July 15, 2015 | K150878 | ILUMIEN OPTIS | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| July 6, 2015 | K151317 | Armada 18 PTA Catheter | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| May 5, 2015 | K150237 | ILUMIEN, Drageonfly OPTIS Imaging Catheter | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142415 | Hi-Torque JET Guide Wire Family | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| December 17, 2014 | K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| August 18, 2014 | K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | DQO | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| August 7, 2014 | K141782 | HI-TORQUE VERSATURN GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| January 30, 2013 | K123369 | ILUMIEN OPTIS | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| January 30, 2013 | K123279 | MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| January 29, 2013 | K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| November 20, 2012 | K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| August 15, 2012 | K121352 | ARMADA 14XXT PTA CATHETER | DQY | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| June 22, 2012 | K121222 | TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| March 6, 2012 | K113464 | NC TREK OTW CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| November 8, 2011 | K112957 | HI-TORQUE POWERTURN | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| November 3, 2011 | K112381 | HI TORQUE CONNECT GUIDEWIRE | DQX | Substantially Equivalent | Lake Region Medical | accessdata.fda.gov |
| October 3, 2011 | K111899 | ARMADA 35/35LL PTA CATHETER | LIT | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 10, 2011 | K111201 | C7 XR IMAGING SYSTEM | NQQ | Substantially Equivalent | Lightlab Imaging, Inc. | accessdata.fda.gov |
| February 11, 2011 | K110134 | NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| February 10, 2011 | K103101 | HI-TORQUE BALANCE MIDDLEWEIGHT ELITE | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| January 10, 2011 | K103110 | MINI TREK(TM) RX AND TREK(TM) RX CORONARY DILATATION CATHETER MINI TREK(TM) OTW AND TREK(TM) OTW DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| December 30, 2010 | K103153 | VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER | LOX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| December 7, 2010 | K102705 | ARMADA 14 PTA CATHETER | LIT | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| July 8, 2010 | K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| June 23, 2010 | K101116 | HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH | DQX | Substantially Equivalent | Abbott Vascular-Cardiac Therapies | accessdata.fda.gov |
| March 11, 2009 | K083738 | HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| February 25, 2009 | K083732 | TAD AND TAD II TAPERED GUIDE WIRES | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| February 6, 2009 | K083706 | HI-TORQUE VERSACORE GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular | accessdata.fda.gov |
| August 18, 2008 | K072708 | ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM | FGE | Unknown | Abbott Vascular-Vascular Solutions | accessdata.fda.gov |
| April 11, 2008 | K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE | DQX | Substantially Equivalent | Abbott Vascular, Inc. | accessdata.fda.gov |
| January 31, 2008 | K072798 | VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER | LIT | Substantially Equivalent | Abbott Vascular-Vascular Solutions | accessdata.fda.gov |
| March 6, 2006 | K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM | FGE | Unknown | Guidant Corporation | accessdata.fda.gov |
| May 15, 2002 | K021228 | HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| September 6, 2001 | K012050 | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER | DQY | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| June 15, 2001 | K011506 | OMNILINK .035 BILIARY STENT SYSTEM | FGE | Unknown | Guidant Corp. | accessdata.fda.gov |
| October 28, 1999 | K992169 | ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991102 | COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 | DTL | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 25, 1999 | K990639 | ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 8, 1999 | K984394 | ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| November 10, 1998 | K982876 | HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 20, 1998 | K980119 | ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| March 13, 1998 | K974773 | HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| August 25, 1997 | K972142 | ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| July 9, 1997 | K971815 | ASC BALANCE MIDDLEWEIGHT GUIDE WIRE | DQX | Substantially Equivalent | Guidant Corp. | accessdata.fda.gov |
| January 22, 1997 | K963702 | ACS HI-TORQUE IRON MAN GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 8, 1996 | K961471 | INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE) | MAV | Unknown | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 15, 1995 | K950752 | ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| April 5, 1995 | K950156 | ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| July 18, 1994 | K942066 | ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| April 13, 1994 | K934624 | ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE | DYB | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
| December 16, 1993 | K934602 | ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| December 9, 1993 | K934339 | LOC GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| June 4, 1993 | K931171 | DOC-TITE(TM) GUIDE WIRE EXTENSION | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| February 12, 1993 | K925381 | ACS HI-TORQUE BALANCE(TM) GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| January 27, 1992 | K914185 | PACEL(TM) FLOW DIRECTED PACING CATHETER | LDF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| October 28, 1991 | K913631 | .014 HI-TORQUE FLOPPY PATHFINDER GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| October 23, 1991 | K913353 | VASCULAR GUIDE WIRE | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| May 7, 1991 | K910645 | DISPOSABLE PATIENT CABLE | DSA | Substantially Equivalent | Diag Corp. | accessdata.fda.gov |
| August 3, 1988 | K881897 | ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW | DQX | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | accessdata.fda.gov |
| February 12, 1988 | K875059 | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE | LDF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| December 4, 1985 | K854261 | ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES | DTL | Substantially Equivalent | Advanced Cardiovascular Systems, Inc. | 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 |
|---|---|---|---|---|---|---|
| April 26, 2024 | P230036 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | NXW | 19 | September 24, 2026 | accessdata.fda.gov |
| March 28, 2014 | P120020 | SUPERA PERIPHERAL STENT SYSTEM | NIP | 36 | March 20, 2026 | accessdata.fda.gov |
| July 31, 2012 | P110043 | OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM | NIO | 14 | January 12, 2026 | accessdata.fda.gov |
| February 22, 2012 | P110028 | ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM | NIO | 25 | October 22, 2025 | accessdata.fda.gov |
| November 1, 2011 | P110019 | Xience Skypoint Everolimus Eluting Coronary Stent System | NIQ | 134 | October 1, 2026 | accessdata.fda.gov |
| July 20, 2011 | P110001 | RX HERCULINK ELITE RENAL STENT SYSTEM | NIN | 21 | October 22, 2025 | accessdata.fda.gov |
| July 2, 2008 | P070015 | XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS | NIQ | 136 | March 24, 2021 | accessdata.fda.gov |
| December 21, 2005 | P050007 | STARCLOSE VASCULAR CLOSURE SYSTEM | MGB | 49 | April 17, 2026 | accessdata.fda.gov |
| September 6, 2005 | P040038 | XACT CAROTID STENT SYSTEM | NIM | 48 | March 20, 2026 | accessdata.fda.gov |
| August 30, 2004 | P040012 | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM | NIM | 64 | October 22, 2025 | accessdata.fda.gov |
| July 16, 2003 | P020047 | MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS | MAF | 74 | June 14, 2023 | accessdata.fda.gov |
| October 2, 1997 | P970020 | MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS | MAF | 80 | September 7, 2022 | accessdata.fda.gov |
| April 30, 1997 | P960043 | PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM | MGB | 131 | September 24, 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 |
|---|---|---|---|---|---|---|
| November 6, 2024 | 95707 | Class II | Ongoing | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon. | Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism. | accessdata.fda.gov |
| March 30, 2022 | 90002 | Class I | Ongoing | Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO | There is a potential that the proximal marker may separate from the imaging catheter | accessdata.fda.gov |
| March 11, 2022 | 89760 | Class II | Ongoing | 20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) | Due to an increase in complaint trend for leaks and intermittent/loose connections. | accessdata.fda.gov |
| March 25, 2020 | 85497 | Class II | Terminated | Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 g/cm, Nominal Everolimus Content: 209 g; Lot number 903224A | Incorrect expiration date | accessdata.fda.gov |
| January 29, 2020 | 84826 | Class I | Terminated | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or | Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. | accessdata.fda.gov |
| May 1, 2019 | 82746 | Class II | Terminated | Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only | Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention. | accessdata.fda.gov |
| July 3, 2018 | 82015 | Class II | Terminated | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices | Incorrect expiration being entered for one lot. | accessdata.fda.gov |
| April 26, 2017 | 77131 | Class I | Terminated | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalizati | Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent. | accessdata.fda.gov |
| March 22, 2017 | 76841 | Class I | Terminated | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 10 | Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. | accessdata.fda.gov |
| February 10, 2017 | 76448 | Class II | Terminated | StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411. | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip. | accessdata.fda.gov |
| February 4, 2016 | 73243 | Class I | Terminated | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 0 | Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture. | accessdata.fda.gov |
| November 25, 2013 | 66971 | Class II | Terminated | HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 101 | Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating. | accessdata.fda.gov |
| August 20, 2012 | 63092 | Class II | Terminated | Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature. | Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating. | accessdata.fda.gov |
| November 30, 2011 | 60906 | Class II | Terminated | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated f | The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness. | accessdata.fda.gov |
| January 7, 2011 | 58979 | Not yet classified | Terminated | Abbott Vascular ACS.035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures. | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization. | accessdata.fda.gov |
| September 10, 2010 | 56973 | Not yet classified | Terminated | RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated fo | The recall was initiated because Abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. If the affected device is used it may result in acute stent deployment difficulties and subsequent intervention. | accessdata.fda.gov |
| October 1, 2009 | 53607 | Not yet classified | Terminated | RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascu | The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength. | accessdata.fda.gov |
| June 17, 2009 | 52705 | Not yet classified | Terminated | POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18 | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. | accessdata.fda.gov |
| May 6, 2009 | 53474 | Not yet classified | Terminated | Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment | Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging. | accessdata.fda.gov |
| May 6, 2009 | 52077 | Not yet classified | Terminated | Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization. | Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure. | accessdata.fda.gov |
| March 19, 2009 | 53477 | Not yet classified | Terminated | Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in | Abbott Vascular is initiating a recall on the XACT Carotid Stent System because the product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action. | accessdata.fda.gov |
| November 5, 2008 | 50192 | Not yet classified | Terminated | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving my | The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining t | accessdata.fda.gov |
| March 17, 2008 | 47361 | Not yet classified | Terminated | 6F Viking Guiding Catheter, Percutaneous catheter, Shape ALR 1.2, Part Number: 1001934-06, Abbott Vascular, Santa Clara, CA 95054. Designed to provide a pathway trough which therapeutic and diagnostic devices are introdu | Mislabeling: The part number on the product label packaging may not match the product. | accessdata.fda.gov |
| July 16, 2007 | 39147 | Not yet classified | Terminated | Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951 | The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing. | accessdata.fda.gov |
| December 5, 2006 | 37019 | Not yet classified | Terminated | ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242 | Specific lots of the.096' and.115' Rotating Hemostatic Valves (RHV) and the Duostat.096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the packaging pouch | accessdata.fda.gov |
| March 22, 2006 | 35099 | Not yet classified | Terminated | Guidant ABSOLUTE.035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563 | Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action. | accessdata.fda.gov |
| August 8, 2005 | 33117 | Not yet classified | Terminated | Guidant OTW OMNILINK.018 &.035 Biliary Stent Systems | This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter. | accessdata.fda.gov |
| January 27, 2005 | 31116 | Not yet classified | Terminated | Voyager RX Coronary Dilatation Catheter | Leak at guide wire exit notch could introduce air into the artery. | accessdata.fda.gov |
| July 15, 2003 | 26836 | Not yet classified | Terminated | Guidant Multi-Link Zeta Coronary Stent System | Potential loss of package sterility. | accessdata.fda.gov |
| May 7, 2003 | 26264 | Not yet classified | Terminated | MULTI-LINK Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13 | Sterility compromised. | accessdata.fda.gov |
| April 1, 2003 | 25945 | Not yet classified | Terminated | Guidant Multi-Link Vision Coronary Stent System Catalog Numbers: 30 different catalog numbers have been listed. The firm indicates that total numbers of devices subject to this removal are being defined. | Complaints that the stents are being dislodged from the delivery system. | accessdata.fda.gov |
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Updated September 24, 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.