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Surge Cardiovascular

Alliant Enterprises, LLC · Model SUC-4300 · UDI-DI 00817278011276

DWF Prescription
10
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
102
Facilities

Description

Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile

Recalls

DateFirmReason
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-07-31Maquet Cardiopulmonary GmbhThe packaging may not consistently maintain sterile barrier integrity.
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-06-24Medtronic Perfusion SystemsPinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati
2026-05-25Medtronic Perfusion SystemsMedtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

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Data 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.