Device product
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Z-1458-2025
Product summary
- Event
- Event 96443
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 320 units
- Official record key
device-enforcement:Z-1458-2025
Official wording
Reason: Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Code information: HEART BASIN PACK-LF, UDI/DI 10195327563561 (ea) 40195327563562 (case), Lot Numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237.
Distribution pattern: US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Derived failure modes
-
Unknown
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.