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3/8'' x 1/4'' x 3/8'' Y Connector

Cardiomed Supplies Inc · Model 2.9 · UDI-DI 36641670004179

DWF
1
510(k) clearances
6,391
Adverse events (303 deaths)
563
Recalls
102
Facilities

Description

This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.

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.