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Surge Cardiovascular
Med Michigan Holdings, LLC · Model PER-1400 · UDI-DI 00817278011092
DWF
Prescription
10
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
102
Facilities
Description
Multiple Perfusion Set, 15" length, one 3" arm, three 10" arms color clamps, Non Sterile
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. |
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