CROME VR MRI SureScan — Class II medical device recall Z-2211-2024
Ongoing recall by Medtronic Inc., reported 2024-07-03, distributed nationwide. Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
| Recall number | Z-2211-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Mounds View, MN, United States |
| Recall initiated | 2024-04-16 |
| Classified | 2024-06-26 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BG, CA, CH, CN, CZ, DE, ES, FR, GB, GR, HR, IE, IS, IT, JO, LV, NL, NO, OM, PA, PL, PT, QA, SE, SI, SK |
| Quantity | 9 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00763000178543, 00763000711382 |
| Serial numbers | RSG601428S, RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S |
| Model numbers | DVPC3D1 |
Product
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Reason for recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
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-2211-2024. 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.