Reported Jul 25, 2018 · Terminated
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The…
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) Trial Screening Lead Kit for Spinal Cord Stimulation
- Models(a) 977D160 (b) 977D260
- 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) 977D160:
146 of 146 codes
VA1M3MM002VA1M3MM003VA1M3MM004VA1M3MM005VA1M3MM006VA1M3MM007VA1M3MM008VA1M3MM009VA1M3MM010VA1M3MM011VA1M3MM012VA1M3MM013VA1M3MM014VA1M3MM015VA1M3MM016VA1M3MM017VA1M3MM018VA1M3MM019VA1M3MM020VA1M3MM021VA1M3MM023VA1M3MM024VA1M3MM025VA1M3MM026VA1M3MM027VA1M3MM028VA1M3MM029VA1M3MM030VA1M3MM031VA1M3MM032VA1M3MM033VA1M3MM036VA1M3MM037VA1M3MM038VA1M3MM039VA1M3MM041VA1M3MM042VA1M3MM044VA1M3MP035VA1M3MP037VA1M3MP038VA1M3MP039VA1M3MP040VA1M3MP041VA1M3MP042VA1M3MP043VA1M3MP044VA1M3MP045VA1M3MQ003VA1M3MQ012VA1M3MQ014VA1M3MQ018VA1M3MQ023VA1M3MQ025VA1M3MQ026VA1M3MQ027VA1M3MQ028VA1M3MQ029VA1M3MQ030VA1M3MQ038
- VA1MTN7044 VA1MTN7045 (b) 977D260
2,565 of 2,565 codes
021435537602143553770214355378021435537902143553800214355701021435570202143557030214355704021435570502143557060214355707021435570802143557090214355710021435571102143557120214355713021435571402143557150214355716021435571702143557180214355719021435572002143557210214355722021435572302143557240214355725021435572602143557270214355728021435572902143557300214355731021435573202143557330214355734021435573502143557360214360663021436066402143606650214370973021439828102143982820214398284021439828502143982860214398288021439829002143982920214398293021439829502143982960214398298021439830002143983020214430302
- Serial Numbers(a) 977D160:
- Amount recalled
- 10,800 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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