FDA recall record · openFDA

Bard Peripheral Vascular Inc

14 FDA recalls on record (2023–2025) — 14 device. 14 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to damage to outer tray that can potentially compromise the sterile barrier 1

Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy 1

The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wi 1

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of cathete 1

Due to guidewires being manufactured incorrectly with the guidewires being mis-assembled within the hoop such that the p 1

Recalls

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: Class I 2025-02-05 Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060 Class II 2025-12-12 Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, Class II 2025-11-06 Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Vencl Class II 2025-08-21 The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedur Class II 2024-09-04 Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu Class II 2024-07-10 Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 Class II 2024-09-30 BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Bio Class II 2024-08-02 Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM Class II 2023-04-11 BD Recanalization System, REF: BDRECANSYSTEM Class II 2023-11-14 Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter R Class II 2023-01-04 Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 Class II 2023-08-10 Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK Class II 2023-02-28 Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G Class II 2023-11-08

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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