FDA Device recall Z-2159-2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
- FDA Device
- Class II
- ongoing
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 by Medtronic Neuromodulation, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2159-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-09 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Reason
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.
Identifiers
| code_info | a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2159-2021%22
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