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Bio-Medicus®
MEDTRONIC, INC. · Model 98000-156 · UDI-DI 00613994504692
1
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
101
Facilities
Description
CANNULA 98000-156 BIO-MED ART 15 O/HOLE
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 | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-06-24 | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-06-24 | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-06-24 | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-06-24 | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-06-24 | Medtronic Perfusion Systems | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary byp |
| 2026-05-25 | Medtronic Perfusion Systems | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. |
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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.