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Medtronic Neuromodulation recalls Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Recalled January 5, 2022 · FDA recall Z-0418-2022 · Medtronic Neuromodulation
Hazard
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive. · FDA Class II
Units
10,006 units
Sold at
Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Brazil, Colombia, Thailand, and Hong Kong.
Description
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →