FDA-Device2022-06-01Class II
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Medtronic Neuromodulation
Hazard
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Sold states
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.
Affected count
14164 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1128-2022Don't want to check this manually?
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