Official recall notice

FDA DeviceClass IINotable

FDA Recall: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascul

Recall date
2026-07-22
FDA class
Class II

Why it was recalled

Hazard

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Product description

Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.

Affected products

MATNR 00763000116019/UDI/DI 00643169769076, Lot Number: 230257001

Verify with the official notice →
Share:

Related Recalls

2026-08-05 · FDA_DEVICE
FDA Recall: EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return ca
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a
Medtronic Perfusion Systems