Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
This recall is currently active, issued July 9, 2021. It was issued by Medtronic Neuromodulation.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- July 9, 2021
- Recall Number
- Z-2159-2021
- Quantity
- 1131 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
Lot / Code Info
a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377
Root Cause
Error in labeling
Action Taken
The firm initiated the recall on 07/07/2021 by regionally approve method (e.g. courier, registered mail, hand delivery). The firm is requesting the return of the devices.