Medtronic DLP Aortic Root Cannula with Flow-Guard — Class II medical device recall Z-0289-2025
Ongoing recall by Medtronic Perfusion Systems, reported 2024-11-13, distributed in IL, MI, NJ, NY, OH, TN, WI. There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a
| Recall number | Z-0289-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2024-10-03 |
| Classified | 2024-11-04 |
| Reported by FDA | 2024-11-13 |
| Distributed | IL, MI, NJ, NY, OH, TN, WI |
| Countries outside the US | AU, SG |
| Quantity | 420 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 20613994495451 |
| Lot numbers | 2023050066, 202307C101, 202401C304 |
| Model numbers | 11012 |
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Reason for recall
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0289-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.