Medtronic Percept PC BrainSense Implantable Neurostimulator Recall: Risk During Cardiac
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61661-medtronic-percept-pc-brainsense-implantable-neurostimulator-recall-risk-during-cardiac.
Source Summary by GovInfoNow · govinfonow.com/recall/61661-medtronic-percept-pc-brainsense-implantable-neurostimulator-recall-risk-during-cardiac · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0418-2022
Cite this page
“Medtronic Percept PC BrainSense Implantable Neurostimulator Recall: Risk During Cardiac.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61661-medtronic-percept-pc-brainsense-implantable-neurostimulator-recall-risk-during-cardiac. Based on FDA recall #Z-0418-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0418-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Medtronic- Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator- Category
Medical device
What to do — step by step
Check Device Model
Verify your device model is B35200 and check the serial number against the list of affected units provided in the recall.
Contact Medtronic
If your device is listed, contact Medtronic directly to discuss next steps for device replacement or repair.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0418-2022 (October 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0418-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.