FDA Device recall Z-2431-2018
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead…
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead… by Medtronic Neuromodulation, citing 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 diffi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2431-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-25 |
| Published | 2018-07-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
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
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.
Identifiers
| code_info | Serial Numbers: (a) 977D160: VA1M3MM002 VA1M3MM003 VA1M3MM004 VA1M3MM005 VA1M3MM006 VA1M3MM007 VA1M3MM008 VA…Serial Numbers: (a) 977D160: VA1M3MM002 VA1M3MM003 VA1M3MM004 VA1M3MM005 VA1M3MM006 VA1M3MM007 VA1M3MM008 VA1M3MM009 VA1M3MM010 VA1M3MM011 VA1M3MM012 VA1M3MM013 VA1M3MM014 VA1M3MM015 VA1M3MM016 VA1M3MM017 VA1M3MM018 VA1M3MM019 VA1M3MM020 VA1M3MM021 VA1M3MM023 VA1M3MM024 VA1M3MM025 VA1M3MM026 VA1M3MM027 VA1M3MM028 VA1M3MM029 VA1M3MM030 VA1M3MM031 VA1M3MM032 VA1M3MM033 VA1M3MM036 VA1M3MM037 VA1M3MM038 VA1M3MM039 VA1M3MM041 VA1M3MM042 VA1M3MM044 VA1M3MP035 VA1M3MP037 VA1M3MP038 VA1M3MP039 VA1M3MP040 VA1M3MP041 VA1M3MP042 VA1M3MP043 VA1M3MP044 VA1M3MP045 VA1M3MQ003 VA1M3MQ012 VA1M3MQ014 VA1M3MQ018 VA1M3MQ023 VA1M3MQ025 VA1M3MQ026 VA1M3MQ027 VA1M3MQ028 VA1M3MQ029 VA1M3MQ030 VA1M3MQ038 VA1M3MQ039 VA1MSCR002 VA1MSCR003 VA1MSCR004 VA1MSCR005 VA1MSCR006 VA1MSCR007 VA1MSCR008 VA1MSCR009 VA1MSCR010 VA1MSCR011 VA1MSCR012 VA1MSCR013 VA1MSCR014 VA1MSCR015 VA1MSCR016 VA1MSCR017 VA1MSCR018 VA1MSCR019 VA1MSCR020 VA1MSCR |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2431-2018%22
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