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Medtronic Neuromodulation recalls Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Recalled June 1, 2022 · FDA recall Z-1128-2022 · Medtronic Neuromodulation
Hazard
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. · FDA Class II
Units
14164 units
Sold at
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.
Description
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Product
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →