Bard Peripheral Vascular Inc

Complete recall history across all FDA and CPSC categories — 136 total recalls

Bard Peripheral Vascular Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (136)

FDA medical device enforcement actions by Bard Peripheral Vascular Inc. Showing most recent 50.

Date Product Reason Class
Dec 12, 2025 Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ing... Due to damage to outer tray that can potentially compromise the sterile barrier Class II
Nov 6, 2025 Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, Acute drainage catheters, indicated for use in removing fluid during acute dr... Class II
Aug 21, 2025 Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to iden... Software version 3.35 of the Venclose digiRF Generator incorporates a cathete... Class II
Feb 5, 2025 Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x... Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps i... Class I
Sep 30, 2024 Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 1... Disposable biopsy instruments were potentially manufactured missing the backe... Class II
Sep 4, 2024 The EVSRF catheter is a sterile, single-use disposable medical device for end... The Venclose" RF Ablation Catheters may have been manufactured with internal ... Class II
Aug 2, 2024 BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN161... Due to possible packaging damage (indentations/cuts) cause by manufacturing p... Class II
Jul 10, 2024 Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended f... Due to guidewires being manufactured incorrectly with the guidewires being mi... Class II
Nov 14, 2023 BD Recanalization System, REF: BDRECANSYSTEM Recanalization systems may be in a manufacturing mode that allows the system ... Class II
Nov 8, 2023 Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Missi... The internal diameter of the coaxial cannula may be smaller or larger than th... Class II
Aug 10, 2023 Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disp... Class II
Apr 11, 2023 Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM;... Coaxial cannula internal diameter and length of biopsy instruments exceed the... Class II
Feb 28, 2023 Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK;... The external diameter of the biopsy instrument is larger than the internal di... Class II
Jan 4, 2023 Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair... Due to the adhesive provided within the catheter repair kits maybe hardened/c... Class II
Dec 22, 2022 The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis... An increase in the reported complaint rate for inability to deploy was identi... Class II
Apr 22, 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 nee... Class II
Jan 20, 2022 Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle ... Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 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
Jan 20, 2022 ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 LUMBAR PUNCTURE TRAY ADULT 18G X 3.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 LUMBAR PUNCTURE DRUG FREE TRAY 22G Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 SAFE-T PLUS ATRAUMATIC ADULT LP TRAY Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Jan 20, 2022 LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Due to lumbar puncture tray manometer failure mode of leaking and mating issues. Class II
Aug 24, 2021 Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/... Due to misbranded products shipped to customers. Class II
Aug 24, 2021 Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiratio... Due to misbranded products shipped to customers. Class II
Jul 27, 2021 REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle,... Potential for needle protector to become fully dislodge exposing infusion nee... Class II
Jun 23, 2021 TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79... Due to complaints received regarding incomplete/open packaging seals potentia... Class II
Jun 23, 2021 EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen C... Due to complaints received regarding incomplete/open packaging seals potentia... Class II
Jun 23, 2021 TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acqu... Due to complaints received regarding incomplete/open packaging seals potentia... Class II
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration,... Class II
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration,... Class II
Mar 25, 2021 PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-... Catheters may experience difficulty in flushing, infusion, and/or aspiration,... Class II
Jan 14, 2021 BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm R... Due to the Penetration Depth Switch used to select the desired penetration de... Class II
Dec 14, 2020 VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL1... Reports of the proximal end of the stent not immediately expanding upon deplo... Class II
Dec 14, 2020 VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10... Reports of the proximal end of the stent not immediately expanding upon deplo... Class II
Dec 14, 2020 VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14... Reports of the proximal end of the stent not immediately expanding upon deplo... Class II
Oct 1, 2020 Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ75... Dilation catheter packaged with the wrong size balloon. The labeling states t... Class II
Mar 17, 2020 Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 A... Sterility compromised due to packaging pouches that may not be sealed properly Class II
Jan 15, 2020 BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Sept... The catheter locks for the lot may contain an 8Fr catheter lock instead of a ... Class II
Jan 3, 2020 Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, package... Lot numbers and products inadvertently not included in the scope of the previ... Class II
Jan 3, 2020 Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged i... Lot numbers and products inadvertently not included in the scope of the previ... Class II
Jan 3, 2020 Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, pack... Lot numbers and products inadvertently not included in the scope of the previ... Class II
Jan 3, 2020 Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged... Lot numbers and products inadvertently not included in the scope of the previ... Class II
Oct 25, 2019 BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core nee... During the firm's review of May 2019 complaint data, a significant increase i... Class II
Oct 1, 2019 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570... Firm has identified that the product may be at risk of incorrectly containing... Class II
Oct 1, 2019 1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-... Firm has identified that the product may be at risk of incorrectly containing... Class II

View all 136 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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