Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A2...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2432-2018.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2432-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Medtronic Neuromodulation or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2432-2018.
Medtronic Neuromodulation
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Medtronic Neuromodulation Recall FAQ
Medtronic Neuromodulation is the subject of a medical implants safety report: Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A2.... The notice was published on May 25, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 8,182 units are potentially affected.