Reported Jan 5, 2022 · Ongoing
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Model B35200 - Percept PC BrainSense Implantable Neurostimulator
- Lot codes and dates
- GTIN 00763000253363
- Serial Numbers
2,714 of 2,714 codes
NPI714835HNPI714811HNPI714812HNPI714814HNPI714816HNPI714817HNPI714819HNPI714820HNPI714750HNPI714764HNPI714771HNPI714794HNPI714682HNPI714709HNPI714710HNPI714594HNPI714598HNPI714599HNPI714602HNPI714603HNPI714606HNPI714564HNPI714572HNPI714574HNPI714587HNPI714588HNPI714589HNPI714373HNPI714379HNPI714331HNPI714346HNPI714358HNPI714378HNPI714128HNPI714160HNPI714060HNPI713947HNPI713956HNPI713957HNPI714001HNPI714017HNPI713948HNPI713949HNPI713951HNPI713952HNPI713953HNPI713954HNPI713955HNPI713829HNPI713371HNPI713372HNPI713422HNPI713242HNPI713188HNPI712940HNPI712785HNPI712637HNPI712405HNPI712411HNPI712412H
- Amount recalled
- 10,006 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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