Medtronic recalls Vectris Trial Screening Lead Kits (models 977D160 and 977D260) due to a potential manufacturing defect in the curved tip introducer needle that may cause difficulty advancing or withdrawing the lead during spinal cord stimulation implantation.
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.
Medtronic is recalling Vectris Trial Screening Lead Kits for spinal cord stimulation (models 977D160 and 977D260) because of a potential manufacturing defect in the curved tip introducer needle. This could make it difficult to properly advance or withdraw the lead during implantation, though serious injury is not expected.
The curved tip introducer needle in the kit may have a manufacturing defect that causes it to be difficult to advance or withdraw the Vectris lead during spinal cord stimulation implantation. This could lead to complications during the procedure but does not typically cause serious injury.
Patients using these specific spinal cord stimulation lead kits for pain therapy are affected. The risk is low as the defect may cause difficulty during implantation but does not typically result in serious injury.
Check your Vectris Trial Screening Lead Kit for spinal cord stimulation (models 977D160 and 977D260) with serial numbers listed in the recall notice. The kits are used for spinal cord stimulation pain therapy procedures.
Verify your kit's model and serial numbers against the list provided in the recall notice to confirm if it's affected.
Reach out to Medtronic directly for guidance on next steps if your kit is affected.
The recall is for a potential manufacturing defect in the curved tip introducer needle that may cause difficulty advancing or withdrawing the lead during implantation. Serious injury is not expected, so the risk is low.
Check your kit's model and serial numbers against the list in the recall notice. If affected, contact Medtronic for guidance.
Affected kits have model numbers 977D160 or 977D260 with specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2431-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2431-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
