Medtronic Intracoronary Shunts: a) ClearView¿ 1 — Class II medical device recall Z-1803-2024
Ongoing recall by Medtronic Perfusion Systems, reported 2024-05-22. Potential for unsealed sterile packing.
| Recall number | Z-1803-2024 |
|---|---|
| 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 | 1,410 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00885074257433, 20885074257116, 20885074257406, 20885074257437 |
| Lot numbers | 2023040542, 2023041002, 2023041455, 202305C173, 202306C205, 2023081208 |
| Model numbers | 31100, 31125, 31200 |
Product
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
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-1803-2024. 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.