Bard Peripheral Vascular, Inc.
Bard Peripheral Vascular, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 139 FDA device recalls on record.
Top product codes for Bard Peripheral Vascular, Inc.
FDA recalls by Bard Peripheral Vascular, Inc.
10 most recent of 139- Z-1367-2026 — Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
- Z-0887-2026 — Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
- 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).
- 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
- 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
- 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.
- 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.
- 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.
- Z-0676-2024 — BD Recanalization System, REF: BDRECANSYSTEM
- 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bard Peripheral Vascular, Inc.
- K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K260012 — UltraScore Focused Force PTA Balloon
- K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit
- K250219 — Dorado PTA Balloon Dilatation Catheter
- K243642 — UltraCor Twirl Breast Tissue Marker
- K242757 — Rotarex Atherectomy System
- K241946 — PeritX 1L Drainage Kit (90-1010) +12 more
- K232737 — PowerPort ClearVUE Slim ECG Enabled Implantable Port +3 more
- K221440 — Liverty TIPS Access Set
- K211410 — GlidePath 13F Long-Term Hemodialysis Catheter
- K192948 — EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G
- K192318 — Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
- K180061 — UltraCor Twirl Breast Tissue Marker
- K171953 — Bard Mission Disposable Core Biopsy Instrument
- K163420 — UltraScore Focused Force PTA Balloon
- K161986 — SIDEKICK and USHER Support Catheters
- K152510 — UltraCor Twirl Breast Tissue Marker
- K142261 — Ultraverse 035 PTA Balloon Dilatation Catheter
- K133948 — BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
- K133569 — TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
- K131199 — ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
- K120722 — RIVAL PTA DILATATION CATHETER
- K120971 — ATLAS PTA BALLOON DILATATION CATHETER
- K120660 — CONQUEST 40 PTA DILATATION CATHETER
- K103367 — SEEKER CROSSING SUPPORT CATHETER
- K063532 — BARD E LUMINEXX BILIARY STENT
- K072283 — DORADO PTA BALLOON DILATATION CATHETER
- K052578 — BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
- K052282 — VENAFLO II VASCULAR GRAFT
- K052114 — BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
- K052236 — BARD ATLAS PTA BALLOON DILATATION CATHETER
- K050832 — FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
- K050049 — DYNAFLO BYPASS GRAFT
- K042062 — PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
Data sourced from openFDA. This site is unofficial and independent of the FDA.