Reported Jun 1, 2022 · Ongoing
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
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?
- Percept BrainSense Implantable Neurostimulator (INS), Model B35200
- Lot codes and dates
- ModelB35200
- Expiration Range11/14/2021-02/14/2024
- GTIN/UPN00763000253363
- Serial Numbers
2,709 of 2,709 codes
NPI702363HNPI702456HNPI702503HNPI702504HNPI702543HNPI702551HNPI702575HNPI703408HNPI703516HNPI703553HNPI703635HNPI703969HNPI703972HNPI704070HNPI704084HNPI704097HNPI704103HNPI704104HNPI704106HNPI704107HNPI704117HNPI704118HNPI704120HNPI704121HNPI704122HNPI704123HNPI704124HNPI704125HNPI704126HNPI704127HNPI704128HNPI704129HNPI704130HNPI704131HNPI704132HNPI704133HNPI704134HNPI704135HNPI704136HNPI704137HNPI704138HNPI704140HNPI704145HNPI704146HNPI704147HNPI704152HNPI704153HNPI704156HNPI704157HNPI704158HNPI704159HNPI704160HNPI704161HNPI704163HNPI704164HNPI704165HNPI704166HNPI704172HNPI704173HNPI704178H
- Amount recalled
- 14164 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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