Medtronic Vectris SureScan MRI — Class II medical device recall Z-2159-2021
Ongoing recall by Medtronic Neuromodulation, reported 2021-08-04. Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information p
| Recall number | Z-2159-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2021-07-09 |
| Classified | 2021-07-28 |
| Reported by FDA | 2021-08-04 |
| Countries outside the US | AT, BE, BR, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IT, NL, NO, PL, PT, RO, SE, SK |
| Quantity | 1,131 units |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00763000324353, 00763000324360, 00763000324377 |
Product
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Reason for recall
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
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-2159-2021. 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.