Device product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Z-0289-2025
Product summary
- Event
- Event 95507
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 420 units
- Official record key
device-enforcement:Z-0289-2025
Official wording
Reason: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Code information: UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Distribution pattern: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Derived failure modes
-
Unknown
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal