medical Class II Updated 2024-11-13

Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012

Recalled Product

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery


Hazard / Issue

There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal

Issued by

FDA

Affected States: NY, OH, IL, NJ, MI, TN, WI
Lot/Code Info: UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
View official government recall

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