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Medtronic Neuromodulation Recall 89994

Description: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Medtronic Neuromodulation Recall 89994 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1129-2022
Event ID89994
Event DescriptionPercept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Product TypeDevices
DistributionWorldwide 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.
Quantity1 unit
Recall ReasonThe Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Device Classification20220601
Device Code InfoModel: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Center Classification Date20220524
Recall Initiation Date20220330
Recalling FirmMedtronic Neuromodulation
Initial Notification Letter
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