Medtronic recalls Model B35200 Percept PC BrainSense Implantable Neurostimulators that may become unresponsive during cardioversion procedures, potentially causing circuit damage. Affected units have specific serial numbers listed in the 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.
Medtronic is recalling certain Percept PC BrainSense implantable neurostimulators (Model B35200) because they can become unresponsive during cardioversion procedures, which are used to correct abnormal heart rhythms. This risk could damage the device's circuit electronics.
During cardioversion procedures (a treatment for irregular heartbeats), the device's circuit electronics can be damaged, causing it to become unresponsive. This may lead to the device failing to function properly after the procedure.
Patients with Medtronic Percept PC BrainSense implantable neurostimulators who have the specific model B35200 and listed serial numbers are affected. Those who have undergone cardiac procedures with a cardiologist may be at higher risk.
Check if your device has the model number B35200 and the specific serial numbers listed in the recall (NPI714835H and other codes). The recall includes over 1,000 serial numbers.
Verify your device model is B35200 and check the serial number against the list of affected units provided in the recall.
If your device is listed, contact Medtronic directly to discuss next steps for device replacement or repair.
The recalled device is the Model B35200 Percept PC BrainSense Implantable Neurostimulator.
Check the serial number on your device against the list of affected serial numbers provided in the recall (NPI714835H and other codes).
No, but you should check if your device is affected and contact Medtronic if it is listed. The device may become unresponsive during cardioversion procedures, so it's important to follow up with your healthcare provider.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0418-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0418-2022 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
