Data / Medical devices / United States / Bard Peripheral Vascular, Inc.
Bard Peripheral Vascular, Inc.: FDA-registered device maker in Tempe, AZ, United States, 114 510(k) clearances and 7 PMA approvals
Bard Peripheral Vascular, Inc. is registered with the FDA (registration 2020394) in Tempe, AZ, United States. It lists 48 device types. The FDA files 114 510(k) clearances and 7 PMA approvals under its listings, the newest dated August 14, 2026. 68 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2020394
- Address
- 1625 W 3rd St, Tempe, AZ, United States, 85281
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- March 19, 1998
- Registered through
- 2027
- Brand names listed
- 125 Implant Seeds, Arteriovenous (AV) Sheath Tunneler, Arteriovenous (AV) Sheath Tunneler Sterilization Cassette, Aspirex Thrombectomy System, Atlas Gold PTA Dilatation Catheter, Atlas PTA Balloon Dilatation Catheter, BD EleVation Breast Biopsy System, BD Trek Bone Lesion Biopsy 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. Newest 100 of 114.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 14, 2026 | K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal System | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 12, 2025 | K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 19, 2025 | K252316 | Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| July 10, 2025 | K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 24, 2025 | K243642 | UltraCor Twirl Breast Tissue Marker | NEU | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| February 4, 2025 | K250068 | Venclose digiRF Generator (VCRFG1) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| January 30, 2025 | K242757 | Rotarex Atherectomy System | MCW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 6, 2024 | K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | PNG | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| February 29, 2024 | K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit | DTK | Substantially Equivalent | Bd | accessdata.fda.gov |
| March 31, 2023 | K230356 | Aspirex Thrombectomy System | QEW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 20, 2023 | K223177 | Highlander 014 PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 17, 2022 | K222793 | WavelinQ Generator | GEI | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 21, 2022 | K220270 | Aspirex Thrombectomy System | QEW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 31, 2022 | K221440 | Liverty TIPS Access Set | DYB | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| May 4, 2022 | K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 30, 2022 | K213896 | BD Trek Powered Bone Biopsy System | KNW | Substantially Equivalent | Bard Peripheral Vascular | accessdata.fda.gov |
| September 14, 2021 | K211738 | Rotarex Atherectomy System | MCW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 12, 2021 | K203363 | Crosser iQ CTO Recanalization System | PDU | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| August 3, 2021 | K211806 | Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| July 15, 2021 | K211933 | EleVation Breast Biopsy System | KNW | Substantially Equivalent | Bard Peripheral Vascular | accessdata.fda.gov |
| July 1, 2021 | K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | MSD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| June 4, 2021 | K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | MSD | Unknown | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| April 2, 2021 | K203767 | Pristine Long-Term Hemodialysis Catheter | MSD | Unknown | C B Bard, Inc. | accessdata.fda.gov |
| March 31, 2021 | K210654 | EnCor Breast Biopsy Probe with Rinse Tube | KNW | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| March 1, 2021 | K203275 | Recon Support Catheter | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | MSD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| June 22, 2020 | K200627 | GlidePath 10F Long-Term Dialysis Catheter | MSD | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| March 5, 2020 | K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters | MSD | Unknown | C. R. Bard | accessdata.fda.gov |
| February 4, 2020 | K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization Devices | KRD | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| November 7, 2019 | K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| October 17, 2019 | K192239 | WavelinQ Plus EndoAVF System | PQK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 3, 2019 | K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 3, 2018 | K181323 | Atlas Gold PTA Dilatation Catheter | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 12, 2018 | K172315 | Straub Endovascular System | MCW | Substantially Equivalent | Straub Medical AG | accessdata.fda.gov |
| March 9, 2018 | K180061 | UltraCor Twirl Breast Tissue Marker | NEU | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 13, 2017 | K172932 | True Flow Valvuloplasty Perfusion Catheter | OZT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 22, 2017 | K172571 | ULTRASCORE Focused Force PTA Balloon | PNO | Substantially Equivalent | C. R. Bard | accessdata.fda.gov |
| September 14, 2017 | K171953 | Bard Mission Disposable Core Biopsy Instrument | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| September 11, 2017 | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle | KNW | Substantially Equivalent | Care Fusion | accessdata.fda.gov |
| November 10, 2016 | K162656 | ESU-1 Electrosurgical Generator | GEI | Substantially Equivalent | Tva Medical, Inc. | accessdata.fda.gov |
| September 9, 2016 | K160754 | Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) | GEI | Substantially Equivalent | Venclose, Inc. | accessdata.fda.gov |
| August 4, 2016 | K161986 | SIDEKICK and USHER Support Catheters | DQY | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| July 19, 2016 | K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | KNW | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| May 24, 2016 | K161208 | CROSSER CTO Recanalization Catheter | PDU | Substantially Equivalent | Bard Peripheral Vacular, Inc. | accessdata.fda.gov |
| May 13, 2016 | K152510 | UltraCor Twirl Breast Tissue Marker | NEU | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| February 18, 2016 | K152136 | Recovery Cone Removal System | MMX | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 17, 2015 | K150667 | True Dilatation Balloon Valvuloplasty Catheter | OZT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 12, 2015 | K143522 | Presto Inflation Device | MAV | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| September 24, 2014 | K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| September 18, 2014 | K141985 | TRUE BA V BALLOON VALVULOPLASTY CATHETER | OZT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 2, 2014 | K140856 | BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS | KXK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| February 21, 2014 | K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 30, 2013 | K130792 | LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM | FGE | Unknown | C.R. Bard, Inc. | accessdata.fda.gov |
| August 2, 2013 | K131493 | SIDEKICK AND USHER SUPPORT CATHETERS | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 2, 2013 | K131002 | VIDA PTV DILATATON CATHETER | OMZ | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 27, 2013 | K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | NEU | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| May 30, 2013 | K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123911 | SENOMARK ULTRA BREAST TISSUE MARKER | NEU | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 11, 2012 | K121856 | ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION | LIT | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| April 19, 2012 | K120971 | ATLAS PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| March 15, 2012 | K120660 | CONQUEST 40 PTA DILATATION CATHETER | LIT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 17, 2011 | K112308 | CROSSER RECANALIZATION SYSTEM | PDU | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| July 13, 2011 | K111850 | VACCESS PTA DILATATION CATHETER | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 16, 2011 | K111100 | ENCOR ENSPIRE BREAST BIOPSY SYSTEM | KNW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 27, 2010 | K103359 | FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) | KNW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 13, 2010 | K103459 | VASCUTRAK PTA DILATATION CATHETER | PNO | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 8, 2010 | K103367 | SEEKER CROSSING SUPPORT CATHETER | DQY | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| December 23, 2009 | K093663 | RADIONUCLIDE BRACHYTHERAPY SOURCE | KXK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 19, 2009 | K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 | DXT | Substantially Equivalent | Flowcardia, Inc. | accessdata.fda.gov |
| March 18, 2009 | K090547 | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U | NEU | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 24, 2008 | K083657 | CONQUEST PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| October 15, 2008 | K082681 | VACORA VACUUM ASSISTED BIOPSY SYSTEM | KNW | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| May 30, 2008 | K063532 | BARD E LUMINEXX BILIARY STENT | FGE | Unknown | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| September 19, 2007 | K072283 | DORADO PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| January 30, 2007 | K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL | NEU | Substantially Equivalent | Inrad | accessdata.fda.gov |
| April 19, 2006 | K060636 | PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE | KXK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| March 23, 2006 | K060487 | LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM | FGE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| December 21, 2005 | K053404 | LIFESTENT FLEXSTART BILIARY STENT SYSTEM | FGE | Unknown | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 20, 2005 | K052282 | VENAFLO II VASCULAR GRAFT | DSY | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| August 24, 2005 | K052132 | MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM | FGE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| May 16, 2005 | K051158 | ENCOR 7 GAUGE | KNW | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| February 7, 2005 | K050090 | GEL MARK V | NEU | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| February 2, 2005 | K043246 | BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS | KXK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| January 31, 2005 | K050049 | DYNAFLO BYPASS GRAFT | DSY | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| September 30, 2004 | K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE | KCT | Substantially Equivalent | Bard Peripheral Vascular, Inc. | accessdata.fda.gov |
| September 20, 2004 | K042341 | ULTRACLIP II US | NEU | Substantially Equivalent | Inrad | accessdata.fda.gov |
| August 19, 2004 | K042098 | SENORX INTRODUCER | GEI | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| July 2, 2004 | K041576 | SOURCELINK | KXK | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| June 3, 2004 | K041201 | ULTRACLIP II MR | GDW | Substantially Equivalent | Inrad | accessdata.fda.gov |
| April 30, 2004 | K040842 | SENORX BIOPSY DEVICE II | KNW | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| April 8, 2004 | K040706 | GEL MARK IV | NEU | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| May 20, 2003 | K030518 | AMERITEK SURE-POINT TRACKER SYSTEM | ITX | Substantially Equivalent | Amertek Medical, Inc. | accessdata.fda.gov |
| March 28, 2003 | K023210 | SEEDLINKS, MODELS 70301, 70302, 70303 | KXK | Substantially Equivalent | Sourcetech Medical, LLC | accessdata.fda.gov |
| March 17, 2003 | K024183 | ALTON PT STEPPER | KXK | Substantially Equivalent | Alton Design, LLC | accessdata.fda.gov |
| February 6, 2002 | K013751 | HANDHELD GAMMA FINDER (HGF) | IZD | Substantially Equivalent | Silicon Instruments Gmhb | accessdata.fda.gov |
| January 29, 2002 | K013641 | SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS | GEI | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| July 16, 2001 | K011402 | BIOPSY SITE MARKER | FZP | Substantially Equivalent | Senorx, Inc. | accessdata.fda.gov |
| May 14, 2001 | K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | DYF | Substantially Equivalent | Impra, Inc. | accessdata.fda.gov |
| March 27, 2001 | K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | DSY | Substantially Equivalent | Impra, Inc. | accessdata.fda.gov |
| February 4, 2000 | K993785 | ULTRACLIP TISSUE MARKER | GDW | Substantially Equivalent | Inrad | 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 13, 2019 | P180037 | Venovo Venous Stent System | QAN | 14 | June 10, 2026 | accessdata.fda.gov |
| July 30, 2018 | P170042 | Covera Vascular Covered Stent | PFV | 14 | June 10, 2026 | accessdata.fda.gov |
| April 24, 2017 | P160024 | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT | PRL | 14 | September 29, 2025 | accessdata.fda.gov |
| June 17, 2014 | P130029 | FLUENCY PLUS ENDOVASCULAR STENT GRAFT | PFV | 14 | June 22, 2026 | accessdata.fda.gov |
| February 13, 2009 | P070014 | LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM | NIP | 66 | June 10, 2026 | accessdata.fda.gov |
| December 4, 2008 | P080007 | BARD E-LUMINEXX VASCULAR STENT | NIO | 24 | May 26, 2022 | accessdata.fda.gov |
| July 23, 2007 | P060002 | FLAIR ENDOVASCULAR STENT GRAFT | PFV | 36 | October 11, 2018 | 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 20, 2026 | 99590 | Class II | Ongoing | EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model number: ENCPDRIVER) with software | Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009), 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling | accessdata.fda.gov |
| December 12, 2025 | 98222 | Class II | Ongoing | Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 | Due to damage to outer tray that can potentially compromise the sterile barrier | accessdata.fda.gov |
| November 6, 2025 | 97864 | Class II | Ongoing | Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T | Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment | accessdata.fda.gov |
| August 21, 2025 | 97312 | Class II | Ongoing | Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-vol | Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface be | accessdata.fda.gov |
| February 5, 2025 | 96174 | Class I | Ongoing | Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239 | Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding. | accessdata.fda.gov |
| September 30, 2024 | 95491 | Class II | Ongoing | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213 | Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding. | accessdata.fda.gov |
| September 4, 2024 | 95408 | Class II | Ongoing | The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood cir | The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to ove | accessdata.fda.gov |
| August 2, 2024 | 95174 | Class II | Ongoing | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver | Due to possible packaging damage (indentations/cuts) cause by manufacturing process. As a result of the packaging damage, may cause the sterile barrier to be compromised. | accessdata.fda.gov |
| July 10, 2024 | 95039 | Class II | Ongoing | Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis Catheters. Please refer to the applicable catheter Instructions for Use for directions | Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the proximal (stiff) end of the guidewire is located at the distal end of the hoop. Injury could occur if the user attempts to insert the proximal end into the patient. | accessdata.fda.gov |
| November 14, 2023 | 93607 | Class II | Ongoing | BD Recanalization System, REF: BDRECANSYSTEM | Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking. | accessdata.fda.gov |
| November 8, 2023 | 93578 | Class II | Ongoing | Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repe | accessdata.fda.gov |
| August 10, 2023 | 92994 | Class II | Ongoing | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/dis | accessdata.fda.gov |
| April 11, 2023 | 91838 | Class II | Ongoing | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM | Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure. | accessdata.fda.gov |
| February 28, 2023 | 91638 | Class II | Ongoing | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK | The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility. | accessdata.fda.gov |
| January 4, 2023 | 91327 | Class II | Ongoing | Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 06016 | Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). | accessdata.fda.gov |
| December 22, 2022 | 91359 | Class II | Ongoing | The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated. | An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. | accessdata.fda.gov |
| April 22, 2022 | 90201 | Class II | Ongoing | REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO | There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction. | accessdata.fda.gov |
| January 20, 2022 | 89553 | Class II | Ongoing | Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | accessdata.fda.gov |
| August 24, 2021 | 88674 | Class II | Terminated | Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, | Due to misbranded products shipped to customers. | accessdata.fda.gov |
| July 27, 2021 | 88473 | Class II | Ongoing | REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796 | Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick. | accessdata.fda.gov |
| June 23, 2021 | 88314 | Class II | Ongoing | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/As | Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. | accessdata.fda.gov |
| March 25, 2021 | 87656 | Class II | Terminated | PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829500, UDI: (01) 00801741027185 - Product Usage: The port system can be used for infusion of medication | Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements. | accessdata.fda.gov |
| January 14, 2021 | 87316 | Class II | Terminated | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents | Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use. | accessdata.fda.gov |
| December 14, 2020 | 87208 | Class II | Ongoing | VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm | Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system. | accessdata.fda.gov |
| October 1, 2020 | 86510 | Class II | Terminated | Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for th | Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure. | accessdata.fda.gov |
| March 17, 2020 | 85338 | Class II | Terminated | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intende | Sterility compromised due to packaging pouches that may not be sealed properly | accessdata.fda.gov |
| January 15, 2020 | 85476 | Class II | Ongoing | BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials are biocompatible, | The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling. | accessdata.fda.gov |
| January 3, 2020 | 84929 | Class II | Terminated | Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile. | Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples. | accessdata.fda.gov |
| October 25, 2019 | 84421 | Class II | Terminated | BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various | During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples. | accessdata.fda.gov |
| October 1, 2019 | 84914 | Class II | Terminated | 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Si | Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation. | accessdata.fda.gov |
| August 14, 2019 | 84659 | Class II | Terminated | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire.035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflatio | The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degre | accessdata.fda.gov |
| June 14, 2019 | 85510 | Class II | Terminated | EQUISTREAM XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F | Incorrect Peel-Apart Introducer Sheath in Kit. | accessdata.fda.gov |
| May 31, 2019 | 83337 | Class II | Terminated | EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799 | The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter. | accessdata.fda.gov |
| May 2, 2019 | 83303 | Class II | Terminated | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast ab | There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product. | accessdata.fda.gov |
| April 12, 2019 | 84946 | Class II | Terminated | BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: T | The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary | accessdata.fda.gov |
| February 18, 2019 | 84173 | Class II | Terminated | LIFESTREAM Balloon Expandable Vascular Covered Stent. BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire.035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot | Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially | accessdata.fda.gov |
| February 14, 2019 | 84169 | Class II | Ongoing | PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter | Complaints received that products packaged with the incorrect introducer sheath size. | accessdata.fda.gov |
| June 25, 2018 | 82513 | Class II | Completed | POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture | Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS. | accessdata.fda.gov |
| April 16, 2018 | 79896 | Class II | Terminated | BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature. | Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting. | accessdata.fda.gov |
| February 8, 2018 | 79841 | Class II | Completed | POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362 | The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions. | accessdata.fda.gov |
| September 22, 2017 | 78224 | Class II | Terminated | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for | During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Sample, and Self-Activation. | accessdata.fda.gov |
| March 28, 2017 | 76914 | Class II | Terminated | MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 Product Usage: The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for | It may be at risk of containing a non-MR compatible GHIATAS Beaded Breast Localization Wire instead of a MR compatible GHIATAS Beaded Breast Localization Wire. | accessdata.fda.gov |
| July 6, 2016 | 74663 | Class II | Terminated | Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue su | May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. | accessdata.fda.gov |
| February 9, 2016 | 73365 | Class II | Terminated | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. | Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking. | accessdata.fda.gov |
| February 4, 2016 | 73249 | Class II | Terminated | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidne | Bard Peripheral Vascular, Inc. is recalling Bard TruGuide Disposable Coaxial Biopsy Needles because they have the potential to have the incorrect sized blunt tip stylet within its packaging that will not pass through the coaxial. | accessdata.fda.gov |
| January 5, 2016 | 73022 | Class II | Terminated | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels. | Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft. | accessdata.fda.gov |
| October 19, 2015 | 72459 | Class II | Terminated | FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethy | Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could occur during use. | accessdata.fda.gov |
| April 9, 2015 | 70952 | Class II | Terminated | BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and | The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues. | accessdata.fda.gov |
| March 23, 2015 | 70839 | Class II | Terminated | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124. | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. | accessdata.fda.gov |
| March 17, 2015 | 70733 | Class II | Terminated | Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), | Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues. | accessdata.fda.gov |
| March 13, 2015 | 72945 | Class II | Terminated | Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters. | IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys. | accessdata.fda.gov |
| August 26, 2014 | 69136 | Class II | Terminated | Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is | Bard Peripheral is recalling the Bard DuaLok Breast Lesion Localization Wire because it may be at risk of having portions of the wire protruding from the packaging, thus representing a breach of sterile barrier. | accessdata.fda.gov |
| September 30, 2013 | 66374 | Class I | Terminated | Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo o | Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use. | accessdata.fda.gov |
| May 28, 2013 | 65395 | Class II | Terminated | BARD PERIPHERAL VASCULAR VACCESS PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral | Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. All other product labeling is consistent with the actual 8mm x 4cm balloon | accessdata.fda.gov |
| April 16, 2013 | 65046 | Class II | Terminated | BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy. | Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number combination may have the metal tissue marker separated from the needle prior to use. | accessdata.fda.gov |
| January 23, 2013 | 64276 | Class II | Terminated | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Us | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the sterilization process (non sterile). | accessdata.fda.gov |
| November 3, 2011 | 60347 | Not yet classified | Terminated | The EnCor biopsy probe, designed for use with EnCor and EnCor Enspire Vacuum Assisted Biopsy (VAB) driver systems. The EnCor Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and | This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked EnCor (Trademark) packaging trays, plastic PETG tray the probe is packaged in was cracked. | accessdata.fda.gov |
| May 4, 2010 | 55621 | Not yet classified | Terminated | BARD DORADO PTA BALLOON DILATATION CATHETERS, PRODUCT CODE # DR135412 | The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft. | accessdata.fda.gov |
| October 8, 2009 | 53615 | Not yet classified | Terminated | Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, s | The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was n | accessdata.fda.gov |
| December 23, 2008 | 50745 | Not yet classified | Terminated | Bard E LUMINEXX Biliary Stent, Size: 5mm x 120mm, Product Number: ZBL05120. | This action is being taken because a label for an indicated use was applied to product sizes that are not approved for that use. The incorrect indication for use label stated "Now Approved for Vascular Use". | accessdata.fda.gov |
| September 12, 2008 | 49540 | Not yet classified | Terminated | Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140. | Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option. | accessdata.fda.gov |
| August 29, 2008 | 49405 | Not yet classified | Terminated | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in | Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible. | accessdata.fda.gov |
| May 9, 2008 | 48125 | Not yet classified | Terminated | Bard Recovery Cone Removal System, Catalog Numbers: RC-15. The device is intended for use for percutaneously remove the recovery filter or facilitate the retrieval of foreign objects from the peripheral vascular system. | This action is being taken because the product has a potential for the handle to detach. The handle detachment may result in the device unable to retrieve the filter or foreign body. | accessdata.fda.gov |
| December 20, 2006 | 37021 | Not yet classified | Terminated | G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J | This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity. | accessdata.fda.gov |
| May 1, 2006 | 35201 | Not yet classified | Terminated | Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet, Catalog Number C1816B, Device Listing Number E148687. The Bard TruGuide Coaxial Biopsy Needle is a three-part device consisting of an ou | Manufacturing change that has introduced variability in the length of the inner stylet. When the inner stylet length is inserted into the cannula component, the exposed stylet length may be up to 8mm longer than expected. | accessdata.fda.gov |
| July 21, 2005 | 32921 | Not yet classified | Terminated | Bard Luminexx 3 Biliary Stent and Delivery System | Angiomed Material Review Board reviewing the manufacturing process observed an increase in the internal scrap rate (failure mode: broken stent struts) of nitinol stents and determined the root cause to be a manufacturing change from polymer to aluminum fixtures. | accessdata.fda.gov |
| September 18, 2003 | 27357 | Not yet classified | Terminated | Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124 | Mislabeled. 7mm balloon labeled 12mm | accessdata.fda.gov |
| August 20, 2003 | 27393 | Not yet classified | Terminated | Opti-Plast Balloon Dilatation Catheters | Product intended for distribution outside USA was distributed without premarket notification requirements being met. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous, Cutting/Scoring
- All makers of Catheter, Angioplasty, Peripheral, Transluminal
- All makers of Catheter, Percutaneous
- All makers of Balloon Aortic Valvuloplasty
- All makers of Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- All makers of Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Updated September 25, 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.