Percept PC BrainSense Implantable Neurostimulator recall
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Why was Percept PC BrainSense Implantable Neurostimulator recalled?
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
- Product
- Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 unit
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)