Drug recall
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190…
FDA recall event 80256 · Class II · Medtronic Neuromodulation
Key facts
| Event ID | 80256 |
|---|---|
| Recall numbers | Z-2431-2018, Z-2432-2018 |
| Recalling firm | Medtronic Neuromodulation |
| Product type | Devices |
| Products | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits…, Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or… |
| Initiation date | May 25, 2018 |
| Report date | Jul 25, 2018 |
| Termination date | Dec 11, 2020 |
| 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: