Medtronic recalls Percept BrainSense Implantable Neurostimulator (INS) Model B35200 due to inability to communicate with clinical and patient programmers. Affected units have specific serial numbers and expiration dates. No remedy is listed in the recall notice.
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Medtronic is recalling Percept BrainSense Implantable Neurostimulators (Model B35200) because they cannot communicate with the clinical and patient programming systems. This issue may prevent proper device adjustments and monitoring, but the recall record does not specify a remedy.
The device cannot communicate with the clinical programmer and patient programmer systems, which may prevent proper adjustments and monitoring of the device's function. This could lead to improper treatment settings, but the recall does not specify a risk of injury or harm.
Patients with the Percept BrainSense Implantable Neurostimulator (Model B35200) are affected. The recall includes specific serial numbers and units manufactured between November 2021 and February 2024.
Check if your device has the model number B35200 and serial numbers listed in the recall (e.g., NPI702363H, NPI702456H). The units were manufactured between November 14, 2021 and February 14, 2024.
Verify your device model is B35200 and check the serial number against the list provided in the recall.
The recall record does not list any remedy.
Check if your device has the model number B35200 and serial numbers listed in the recall (e.g., NPI702363H, NPI702456H). The units were manufactured between November 14, 2021 and February 14, 2024.
The recall record does not specify any action steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1128-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1128-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
