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3/16'' x 3/16'' Straight Connector

Cardiomed Supplies Inc · Model 1.7 · UDI-DI 36641670004476

DWF
1
510(k) clearances
6,314
Adverse events (301 deaths)
563
Recalls
101
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 SystemsMedtronic 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
2026-06-24Medtronic Perfusion SystemsMedtronic 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
2026-06-24Medtronic Perfusion SystemsMedtronic 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
2026-06-24Medtronic Perfusion SystemsMedtronic 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
2026-06-24Medtronic Perfusion SystemsMedtronic 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
2026-06-24Medtronic Perfusion SystemsMedtronic 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
2026-05-25Medtronic 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.