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Medtronic Perfusion Systems recalls Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Recalled November 13, 2024 · FDA recall Z-0289-2025 · Medtronic Perfusion Systems
Hazard
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal · FDA Class II
Units
420 units
Sold at
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Description
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →