Medtronic Neuromodulation Recall 88272
Description: Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Medtronic Neuromodulation Recall 88272 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2159-2021 |
| Event ID | 88272 |
| Event Description | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 |
| Product Type | Devices |
| 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 |
| Quantity | 1131 units |
| Recall 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. |
| Device Classification | 20210804 |
| Device Code Info | a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377 |
| Center Classification Date | 20210728 |
| Recall Initiation Date | 20210709 |
| Recalling Firm | Medtronic Neuromodulation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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