Bard Peripheral Vascular Inc
Tempe, AZ, US
BARD PERIPHERAL VASCULAR, INC. appears in FDA device records in Tempe, AZ. FDA records list 39 510(k) clearances between and , 174 PMA records and one registered establishment. As of , FDA records show 240 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Bard Peripheral Vascular Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Bard Peripheral Vasrecall
510(k) clearance history
FDA records hold 39 510(k) clearances for Bard Peripheral Vascular Inc between 2003 and 2026. The busiest year on record is 2005, with 6. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262571 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | KNW | Substantially Equivalent | |
| K260012 | UltraScore™ Focused Force PTA Balloon | PNO | Substantially Equivalent | |
| K252681 | EnCor EnCompass™ Breast Biopsy and Tissue Removal System | KNW | Substantially Equivalent | |
| K250032 | Marquee™ Disposable Core Biopsy Instrument and Instrument Kit | KNW | Substantially Equivalent | |
| K250219 | Dorado™ PTA Balloon Dilatation Catheter | DQY | Substantially Equivalent | |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | NEU | Substantially Equivalent | |
| K242757 | Rotarex Atherectomy System | MCW | Substantially Equivalent | |
| 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 | |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable Port; PowerPort™ isp M.R.I.™ ECG Enabled Implantable Port; PowerPort™ Slim ECG Enabled Implantable Port | LJT | Substantially Equivalent | |
| K221440 | Liverty™ TIPS Access Set | DYB | Substantially Equivalent | |
| K213896 | BD Trek Powered Bone Biopsy System | KNW | Substantially Equivalent | |
| K211933 | EleVation Breast Biopsy System | KNW | Substantially Equivalent | |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | MSD | Unknown | |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | KNW | Substantially Equivalent | |
| K192318 | Ultraverse 014 and 018 PTA Balloon Dilatation Catheters | LIT | Substantially Equivalent | |
| K180061 | UltraCor Twirl Breast Tissue Marker | NEU | Substantially Equivalent | |
| K171953 | Bard Mission Disposable Core Biopsy Instrument | KNW | Substantially Equivalent | |
| K163420 | UltraScore Focused Force PTA Balloon | PNO | Substantially Equivalent | |
| K161986 | SIDEKICK and USHER Support Catheters | DQY | Substantially Equivalent | |
| K152510 | UltraCor Twirl Breast Tissue Marker | NEU | Substantially Equivalent | |
| K142261 | Ultraverse 035 PTA Balloon Dilatation Catheter | LIT | Substantially Equivalent | |
| K133948 | BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT | KNW | Substantially Equivalent | |
| K133569 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM | OZT | Substantially Equivalent | |
| K131199 | ULTRAVERSE RX PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K120971 | ATLAS PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K120722 | RIVAL PTA DILATATION CATHETER | LIT | Substantially Equivalent | |
| K120660 | CONQUEST 40 PTA DILATATION CATHETER | LIT | Substantially Equivalent | |
| K103367 | SEEKER CROSSING SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K063532 | BARD E LUMINEXX BILIARY STENT | FGE | Unknown | |
| K072283 | DORADO PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | |
| K062887 | MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F | DTK | Substantially Equivalent | |
| K052578 | BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J | DTK | Unknown | |
| K052282 | VENAFLO II VASCULAR GRAFT | DSY | Substantially Equivalent | |
| K052114 | BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP | FGE | Unknown | |
| K052236 | BARD ATLAS PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | |
| K050832 | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT | JCT | Substantially Equivalent | |
| K050049 | DYNAFLO BYPASS GRAFT | DSY | Substantially Equivalent | |
| K042062 | PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE | KCT | Substantially Equivalent | |
| K031041 | FLUENCY TRACHEOBRONCHIAL STENT GRAFT | JCT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2020394 | 2020394 | BARD PERIPHERAL VASCULAR, INC. | 1625 W 3rd St, TEMPE, AZ 85281 US | 2026 | and 39 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DWMApparatus, Suction, Patient Care
- DSWBag, Polymeric Mesh, Pacemaker
- OZTBalloon Aortic Valvuloplasty
- FCGBiopsy Needle
- KDQBottle, Collection, Vacuum
- PDUCatheter For Crossing Total Occlusions
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- MSDCatheter, Hemodialysis, Implanted
- DQYCatheter, Percutaneous
- PNOCatheter, Percutaneous, Cutting/Scoring
- MCWCatheter, Peripheral, Atherectomy
- FZPClip, Implantable
- MMXDevice, Percutaneous Retrieval
- KRDDevice, Vascular, For Promoting Embolization
- DWPDilator, Vessel, Surgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DTKFilter, Intravascular, Cardiovascular
- MZYGraft, Vascular, Stainless Steel Tunneler
- PRLIliac Covered Stent, Arterial
- DXTInjector And Syringe, Angiographic
- KNWInstrument, Biopsy
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- NEUMarker, Radiographic, Implantable
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
- QEWPeripheral Mechanical Thrombectomy With Aspiration
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- IZDProbe, Uptake, Nuclear
- JCTProsthesis, Tracheal, Expandable
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- KXKSource, Brachytherapy, Radionuclide
- GDWStaple, Implantable
- NIOStent, Iliac
- QANStent, Iliac Vein
- NIPStent, Superficial Femoral Artery
- FGEStents, Drains And Dilators For The Biliary Ducts
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- MAVSyringe, Balloon Inflation
- IWJSystem, Applicator, Radionuclide, Manual
- PFVSystem, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
- ITXTransducer, Ultrasonic, Diagnostic
- FSHTray, Surgical, Needle
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 240| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1367-2026 | 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 | Class II | Open, Classified | |
| Z-0887-2026 | 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, injury to internal organs or vessels. | Class II | Open, Classified | |
| Z-2638-2025 | 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-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively). | 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 becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation. | Class II | Open, Classified | |
| Z-1244-2025 | 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. | Class I | Open, Classified | |
| Z-0467-2025 | 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. | Class II | Open, Classified | |
| Z-0371-2025 | 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 circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times. | 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 overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature. | Class II | Open, Classified | |
| Z-3206-2024 | 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, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. | 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. | Class II | Open, Classified | |
| Z-3062-2024 | 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 on the use of these accessories. | 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. | Class II | Open, Classified | |
| Z-0676-2024 | 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. | Class II | Open, Classified | |
| Z-0643-2024 | 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 x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM | 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 repeat procedures. | Class II | Open, Classified | |
| Z-0027-2024 | 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/discomfort, pneumothorax, and bleeding. | Class II | Open, Classified | |
| Z-1564-2023 | 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. | Class II | Open, Classified | |
| Z-1260-2023 | 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. | Class II | Open, Classified | |
| Z-1051-2023 | 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 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit | Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). | Class II | Open, Classified | |
| Z-1108-2023 | 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. | Class II | Open, Classified | |
| Z-1273-2022 | 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. | Class II | Open, Classified | |
| Z-0800-2022 | SAFE-T PLUS ATRAUMATIC ADULT LP TRAY | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0799-2022 | LUMBAR PUNCTURE DRUG FREE TRAY 22G | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0798-2022 | ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0797-2022 | SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0796-2022 | LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0795-2022 | LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0794-2022 | SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0793-2022 | ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified | |
| Z-0792-2022 | LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP | Due to lumbar puncture tray manometer failure mode of leaking and mating issues. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain