Bard Peripheral Vascular Inc

FDA Regulatory Profile

Summary

Total Recalls
139 (5 Class I)
510(k) Clearances
38
Inspections
11
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1367-2026Class IIBroviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060December 12, 2025
Z-0887-2026Class IISafe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,November 6, 2025
Z-2638-2025Class IIVenclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anAugust 21, 2025
Z-1244-2025Class IRotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; SFebruary 5, 2025
Z-0467-2025Class IIBard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BASeptember 30, 2024
Z-0371-2025Class IIThe EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency September 4, 2024
Z-3206-2024Class IIBARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN20August 2, 2024
Z-3062-2024Class IIGuidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 FJuly 10, 2024
Z-0676-2024Class IIBD Recanalization System, REF: BDRECANSYSTEMNovember 14, 2023
Z-0643-2024Class IIBard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416November 8, 2023
Z-0027-2024Class IIBard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016August 10, 2023
Z-1564-2023Class IIBard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16April 11, 2023
Z-1260-2023Class IIBard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MFebruary 28, 2023
Z-1051-2023Class IICatalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr BJanuary 4, 2023
Z-1108-2023Class IIThe Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encDecember 22, 2022
Z-1273-2022Class IIREF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,April 22, 2022
Z-0799-2022Class IILUMBAR PUNCTURE DRUG FREE TRAY 22GJanuary 20, 2022
Z-0798-2022Class IIATRAUMATIC ADULT LUMBAR PUNCTURE TRAYJanuary 20, 2022
Z-0795-2022Class IILUMBAR PUNCTURE TRAY ADULT 18G X 3.5January 20, 2022
Z-0790-2022Class IISafe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with ManometerJanuary 20, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K260012UltraScore™ Focused Force PTA BalloonFebruary 4, 2026
K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemDecember 12, 2025
K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitJuly 10, 2025
K250219Dorado™ PTA Balloon Dilatation CatheterJune 17, 2025
K243642UltraCor™ Twirl™ Breast Tissue MarkerMarch 24, 2025
K242757Rotarex Atherectomy SystemJanuary 30, 2025
K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter KiDecember 6, 2024
K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled ImplantDecember 8, 2023
K221440Liverty™ TIPS Access SetMay 31, 2022
K213896BD Trek Powered Bone Biopsy SystemMarch 30, 2022
K211933EleVation Breast Biopsy SystemJuly 15, 2021
K211410GlidePath 13F Long-Term Hemodialysis CatheterJune 4, 2021
K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe -November 7, 2019
K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersOctober 3, 2019
K180061UltraCor Twirl Breast Tissue MarkerMarch 9, 2018
K171953Bard Mission Disposable Core Biopsy InstrumentSeptember 14, 2017
K163420UltraScore Focused Force PTA BalloonJune 14, 2017
K161986SIDEKICK and USHER Support CathetersAugust 4, 2016
K152510UltraCor Twirl Breast Tissue MarkerMay 13, 2016
K142261Ultraverse 035 PTA Balloon Dilatation CatheterSeptember 24, 2014