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TandemLung
CARDIACASSIST, INC. · Model 5730-3118 · UDI-DI 00814112020432
10
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
101
Facilities
Description
TandemHeart blood pump kit with 31 Fr V-V cannula, TandemLung oxygenator, and accessories
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.