FDA Device recall Z-0289-2025
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012 by Medtronic Perfusion Systems, citing there is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-03 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | IL, MI, NJ, NY, OH, TN, WI |
Product
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
Identifiers
| code_info | UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2025%22
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