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Terumo Cardiovascular Systems
Med Michigan Holdings, LLC · Model 816502L · UDI-DI 00817278010859
DWF
Prescription
10
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
102
Facilities
Description
Retrograde Cardioplegia Cannula, Self Inflate, Med Balloon, Rigid Stylet, Sure Touch, Long, 15Fr
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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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.