FDA Device recall Z-2432-2018
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f)…
- FDA Device
- Class II
- terminated
- Published 2018-07-25
On 2018-07-25 the FDA classified a Class II recall of Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f)… 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-2432-2018 |
| 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) 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 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) 977A160: VA1LT6B001 VA1LT6B003 VA1LT6B004 VA1LT6B005 VA1LT6B006 VA1LT6B007 VA1LT6B008 VA1…Serial Numbers: (a) 977A160: VA1LT6B001 VA1LT6B003 VA1LT6B004 VA1LT6B005 VA1LT6B006 VA1LT6B007 VA1LT6B008 VA1LT6B009 VA1LT6B010 VA1LT6B011 VA1LT6B012 VA1LT6B013 VA1LT6B014 VA1LT6B015 VA1LT6B017 VA1LT6B019 VA1LT6B020 VA1LT6B021 VA1LT6B022 VA1LT6B023 VA1LT6B024 VA1LT6B025 VA1LT6B026 VA1LT6B027 VA1LT6B028 VA1LT6B029 VA1LT6B030 VA1LT6B031 VA1LT6B032 VA1LT6B033 VA1LT6B035 VA1LT6B036 VA1LT6B037 VA1LT6B038 VA1LT6B039 VA1LT6B040 VA1LT6B041 VA1LT6B042 VA1LT6B043 VA1LT6B044 VA1LT6B045 VA1LVVU005 VA1LVVU006 VA1LVVU007 VA1LVVU009 VA1LVVU010 VA1LVVU011 VA1LVVU012 VA1LVVU013 VA1LVVU014 VA1LVVU015 VA1LVVU016 VA1LVVU017 VA1LVVU018 VA1LVVU019 VA1LVVU020 VA1LVVU021 VA1LVVU022 VA1LVVU023 VA1M1ZT001 VA1M1ZT002 VA1M1ZT003 VA1M1ZT004 VA1M1ZT007 VA1M1ZT008 VA1M1ZT009 VA1M1ZT010 VA1M1ZT011 VA1M1ZT012 VA1M1ZT016 VA1M1ZT017 VA1M1ZT019 VA1M1ZT020 VA1M1ZT021 VA1M1ZT022 VA1M1ZT025 VA1MK0P001 VA1MK0P002 VA1MK0P003 VA1MK0P004 VA1MK0P0 |
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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-2432-2018%22
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