Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect
Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary measure for a manufacturing defect that causes difficulty in device manipulation, without reported injuries or fatalities.
Plain-English summary
Medtronic Neuromodulation is conducting a voluntary recall of the Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models 977D160 and 977D260. The recall is due to a potential manufacturing defect in the curved tip introducer needle included in the kit.
This defect could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle. The affected kits are used as part of a Neurostimulation system for pain therapy, indicated for the management of chronic, intractable pain of the trunk and/or limbs.
A total of 10,800 units were distributed worldwide. Specific serial numbers for the affected models are listed in the official recall documentation. Healthcare providers and patients should contact Medtronic Neuromodulation for instructions on how to proceed with the recall and replacement of the affected kits.
The recalled product
- 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 Neurost
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 10,800
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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