Vectris — Class II medical device recall Z-2431-2018
Terminated recall by Medtronic Neuromodulation, reported 2018-07-25. This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit,
| Recall number | Z-2431-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2018-05-25 |
| Classified | 2018-07-13 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2020-12-11 |
| Quantity | 10,800 units |
| Serial numbers | 0214355376, 0214355377, 0214355378, 0214355379, 0214355380, 0214355701, 0214355702, 0214355703, 0214355704, 0214355705, 0214355706, 0214355707, 0214355708, 0214355709, 0214355710, 0214355711, 0214355712, 0214355713, 0214355714, 0214355715, 0214355716, 0214355717, 0214355718, 0214355719, 0214355720 and 475 more |
| Model numbers | 977D160, 977D260 |
Product
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 (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: Failed Back Syndrome (FBS) or low back syndrome or failed back; Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; Post laminectomy pain; Multiple back operations; Unsuccessful disk surgery; Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; Peripheral causalgia; Epidural fibrosis; Arachnoiditis or lumbar adhesive arachnoiditis; Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.
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 withdrawing the Vectris lead through the curved tip introducer needle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2431-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.