Recall of Medtronic Vectris Sure Scan MRI Lead Kits (models 977A160, 977A175, 977A190, 977A260, 977A275, 977A290) due to potential manufacturing defect in curved tip introducer needle causing difficulty advancing or withdrawing the lead.
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 specific models of Vectris Sure Scan MRI Lead Kits for Spinal Cord Stimulation because of a potential manufacturing defect in the curved tip introducer needle. This defect could make it difficult to advance or withdraw the spinal cord stimulation lead during implantation. Affected units have model numbers starting with 977A and serial numbers listed in the recall notice.
The curved tip introducer needle in the kit may have a manufacturing defect that causes difficulty advancing or withdrawing the Vectris lead during implantation. This could potentially lead to complications during the surgical procedure, but the risk of serious injury is not described as immediate or high in normal use.
Patients with spinal cord stimulation implants using the affected models are most at risk. The recall applies to specific model numbers and serial numbers listed in the notice.
Check if your device has model numbers starting with 977A (e.g., 977A160, 977A175, 977A190, 977A260, 977A275, 977A290). The full serial numbers are listed in the recall notice for each model.
Identify if your device has model numbers starting with 977A (e.g., 977A160, 977A175, 977A190, 977A260, 977A275, 977A290) and the corresponding serial numbers listed in the recall notice.
The recall affects Vectris Sure Scan MRI Lead Kits for Spinal Cord Stimulation with model numbers starting with 977A (specifically 977A160, 977A175, 977A190, 977A260, 977A275, 977A290).
Check the model number on your device and compare it to the list of affected models starting with 977A. The full serial numbers for each model are listed in the recall notice.
The recall states that the defect could cause difficulty advancing or withdrawing the lead during implantation, but it does not describe a risk of serious injury in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-2432-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-2432-2018 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.
