Reported Jun 1, 2022 · Ongoing
Percept PC 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 PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Lot codes and dates
- ModelB35200
- GTIN/UPN00763000420987
- Serial numberNPI708734H
- Expiration Date10/28/2022
- Amount recalled
- 1 unit
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.
Want the full recall guide?
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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