Medtronic Cardioplegia Adapters: a) DLP¿ 1 — Class II medical device recall Z-1801-2024
Ongoing recall by Medtronic Perfusion Systems, reported 2024-05-22. Potential for unsealed sterile packing.
| Recall number | Z-1801-2024 |
|---|---|
| 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 | 6,290 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00613994619662, 00613994619716, 00613994918550, 20613994619666, 20613994619710, 20613994685937, 20613994756057, 20613994918554, 20613994918585, 20613994918608 |
| Lot numbers | 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040212, 2023040431, 2023040432, 2023040459, 2023040463, 2023040464, 2023040804, 2023040805, 2023041171, 2023041205, 2023041206, 2023041227, 202305C097, 202305C098, 202305C099, 202305C102, 202305C110, 202305C111, 202306C131, 202306C136, 202308C218 |
| Model numbers | 10710, 11001G, 13002, 14000, 14003, 25009, 25010 |
Product
Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003, d) DLP¿ 38.1 cm (15 in) Multiple Perfusion Set, Model Number 14000, e) DLP¿ 50.8 cm (20 in) Extension Line Adapter, Model Number 11001G, f) DLP¿ Perfusion/Venting Adapter, Model Number 13002, g) DLP¿ Y Adapter Coronary Perfusion, Model Number 10710
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-1801-2024. 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.