Recall Z-2159-2021 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
| Date | Jul 9, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 1131 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.