Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga — Class II medical device recall Z-1800-2024
Ongoing recall by Medtronic Perfusion Systems, reported 2024-05-22. Potential for unsealed sterile packing.
| Recall number | Z-1800-2024 |
|---|---|
| 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 | 2024-03-19 |
| Classified | 2024-05-10 |
| Reported by FDA | 2024-05-22 |
| Quantity | 2,622 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00673978178646, 20613994495420, 20613994495499, 20613994676140 |
| Lot numbers | 2023031043, 2023031563, 2023040211, 2023040437, 2023040480, 2023040807, 2023040808, 2023040854, 2023040855, 2023041224, 202305C076, 202305C108, 202305C109, 202306C138, 202306C196 |
| Model numbers | 11014L, 11316, 24009 |
Product
Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Reason for recall
Potential for unsealed sterile packing.
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-1800-2024. 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.