Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Check against the official notice below — it lists the full affected range.
Medtronic is recalling one Percept PC BrainSense Implantable Neurostimulator (model B35200, serial number NPI708734H) due to a communication failure between the device and the clinical or patient programmer systems. The affected device was distributed worldwide, including across all U.S. states and territories, as well as multiple countries including Canada, Australia, Brazil, and others.
The recall record does not specify a remedy or recommended course of 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: 1 unit Lot/code info: Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.