Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 14,164 units of the Percept BrainSense Implantable Neurostimulator (INS), Model B35200, due to a communication failure between the device and both the clinical programmer and patient programmer systems. The affected devices were distributed worldwide, including across all U.S. states and territories, as well as multiple countries in the Americas, Europe, and Asia-Pacific regions. The recalled units have expiration dates ranging from November 2021 to February 2024 and can be identified by specific serial numbers beginning with "NPI702" through "NPI704."
The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Reason for recall: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. 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 Rep Quantity: 14164 units Lot/code info: Model: B35200; Expiration Range: 11/14/2021-02/14/2024; GTIN/UPN: 00763000253363, Serial Numbers: NPI702363H, NPI702456H, NPI702503H, NPI702504H, NPI702543H, NPI702551H, NPI702575H, NPI703408H, NPI703516H, NPI703553H, NPI703635H, NPI703969H, NPI703972H, NPI704070H, NPI704084H, NPI704097H, NPI704103H, NPI704104H, NPI704106H, NPI704107H, NPI704117H, NPI704118H, NPI704120H, NPI704121H, NPI704122H, NPI704123H, NPI704124H, NPI704125H, NPI704126H, NPI704127H, NPI704128H, NPI704129H, NPI704130H, NPI704131H, NPI704132H, NPI704133H, NPI704134H, NPI704135H, NPI704136H, NPI704137H, NPI704138H, NPI704140H, NPI704145H, NPI704146H, NPI704147H, NPI704152H, NPI704153H, NPI704156H, NPI704157H, NPI704158H, NPI704159H, NPI704160H, NPI704161H, NPI704163H, NPI704164H, NPI704165H, NPI704166H, NPI704172H, NPI704173H, NPI704178H, NPI704181H, NPI704182H, NPI704183H, NPI704184H, NPI704185H, NPI704186H, NPI704189H, NPI704190H, NPI704192H, NPI704193H, NPI704194H, NPI704195H, NPI704196H, NPI704197H, NPI704198H, NPI704201H, NPI704202H, NPI704203H, NPI704206H, NPI704208H, NPI704209H, NPI704210H, NPI704211H, NPI704212H, NPI704213H, NPI704217H, NPI704218H, NPI704220H, NPI704221H, NPI704223H, NPI704225H, NPI704226H, NPI704227H, NPI704228H, NPI704230H, NPI704231H, NPI704232H, NPI704233H, NPI704234H, NPI704237H, NPI704240H, NPI704241H, NPI704242H, NPI704243H, NPI704244H, NPI704245H, NPI704246H, NPI704247H, NPI704250H, NPI704251H, NPI704252H, NPI704253H, NPI704254H, NPI704255H, NPI704256H, NPI704257H, NPI704258H
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.