FDAMay 25, 2018device
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 pa...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic neuromodulationmedtronic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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