The FDA has posted 5 enforcement recalls from Bard Peripheral Vascular Inc since 2025, including 1 Class I (most serious) recall. Most recent report: Oct 7, 2026.
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to…
Due to damage to outer tray that can potentially compromise the sterile barrier
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 pos…
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.…
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events.…
Firm name as filed with the FDA: “Bard Peripheral Vascular Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.