FDA Enforcement
Class II
Ongoing
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Recall: Z-0289-2025
·
Reported November 13, 2024
Enforcement
- Recall Number
- Z-0289-2025
- Event ID
- 95507
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2024
- Initiation Date
- October 3, 2024
- Classification Date
- November 4, 2024
- Address
- 7611 Northland Dr N, N/A, Brooklyn Park, MN, 55428-1088, United States
Description
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
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 Info
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Distribution
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Quantity
420 units