Reported Oct 30, 2024 · Ongoing
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 00763000813468Serial Numbers: NND504236H, NND504252H 00763000813475Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H 00763000813529Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H A7630008135201Serial Numbers: NND504167H, NND504178H, NND504180H A7630008134701Serial Numbers: NND504181H, NND504243H - Amount recalled
- 39 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
This product could cause temporary or reversible health problems — stop using it.
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