Reported Jul 25, 2018 · Terminated
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d)…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- 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 UsageThe 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 conditionsFailed 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
- Lot codes and dates
- Serial Numbers(a) 977A160:
138 of 138 codes
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
- VA1P9C0025 VA1P9C0029 (b) 977A175
VA1MNGH001VA1MNGH007VA1MNGH008VA1MNGH009VA1MNGH010VA1MNGH011VA1MNGH012VA1MNGH013VA1MNGH014VA1MNGH015VA1MNGH016VA1MNGH017VA1MNGH018VA1MNGH027VA1MNGH028VA1MNGH029VA1NJZ9005VA1NJZ9013VA1NJZ9014VA1NJZ9023
- VA1NJZ9024 VA1NJZ9025 (c) 977A190
02149341940215017599VA1MHF3001VA1MHF3002VA1MHF3003VA1MHF3004VA1MHF3005VA1MHF3006VA1MHF3007VA1MHF3008VA1MHF3009VA1MHF3010VA1MHF3011VA1MHF3012VA1MHF3013
- VA1MHF3014 VA1NJ6Z037 (d) 977A260
2,531 of 2,531 codes
021434139202143413930214342261021434226202143422630214342264021434226502143422660214342267021434226802143422690214342270021434227102143422720214342273021434227402143422750214342276021434227702143422780214342279021434228002143422810214346866021434686702143468680214346869021434687002143468710214346872021434687302143468740214346959021434696002143470010214347002021434738102143473820214347383021434940102143494020214349403021434940402143494050214349406021447984802144798500214479851021447985202144798530214479854021447985502144798560214479858021447985902144798600214479881021447988202144798840214479887
- Serial Numbers(a) 977A160:
- Amount recalled
- 8182 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Neuromodulation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.