FDA recall Z-0418-2022

Product

Model B35200 - Percept PC BrainSense Implantable Neurostimulator

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2021-10-19

Report date

2022-01-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2022