Recall Z-2431-2018 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
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, as well as additional components used for lead implant as part of a Neurostimulation system for pain therapy. A Medtronic implantable Neurostimulation system is indicated for spinal cord stimulation (
| Date | Jul 13, 2018 (initiated May 25, 2018) |
| Status | Terminated |
| Reason | 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 withdrawing the Vectris lead through the curved tip introducer needle. |
| Root cause | Process control |
| Action | Beginning 25 May 2018, Medtronic sent a letter via mail to affected customers. The notification included the customer letter, confirmation form (reply form), and a list of affected product serial numbers. The letter informed customers of the recall, and provided instructions on the identification and return of affected products. The firm expanded the recall, notifying their consignees by letter on 07/13/2018. Customers with device related questions can contact Technical Services at 1-800-707-0933 weekdays 7am-6pm CT. |
| Quantity | 10,800 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.