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MEDTRONIC, INC. · Model HY9M47R10 · UDI-DI 00763000433451
DWF
Prescription
1
510(k) clearances
6,232
Adverse events (300 deaths)
560
Recalls
101
Facilities
Description
CUSTOM PACK HY9M47R10 ADLT MAIN
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2026-05-25 | Medtronic Perfusion Systems | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. |
| 2026-04-21 | Medtronic Perfusion Systems | Certain lots of product have the potential for a sterile barrier breach. |
| 2026-04-21 | Medtronic Perfusion Systems | Certain lots of product have the potential for a sterile barrier breach. |
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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.