Drug recall
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
FDA recall event 88272 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 88272 |
|---|---|
| Recall numbers | Z-2159-2021 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jul 9, 2021 |
| Report date | Aug 4, 2021 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 2182207 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: