Home › Bard Peripheral Vascular, Inc. › BARD® BRENER
BARD® BRENER
Bard Peripheral Vascular, Inc. · Model S11887002 · UDI-DI 00801741090196
DWF
Prescription
10
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
102
Facilities
Description
BARD® BRENER™ Carotid Bypass Shunt, Tapered Carotid Shunt With Side Arm, 17F - 10F x 13cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | Maquet Cardiopulmonary Gmbh | The packaging may not consistently maintain sterile barrier integrity. |
| 2026-07-31 | Maquet Cardiopulmonary Gmbh | The packaging may not consistently maintain sterile barrier integrity. |
| 2026-07-31 | Maquet Cardiopulmonary Gmbh | The packaging may not consistently maintain sterile barrier integrity. |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-06-24 | Medtronic Perfusion Systems | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati |
| 2026-05-25 | Medtronic Perfusion Systems | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.