Medtronic recalls 12 specific model B35300 implantable neurostimulators that fail to communicate with the A610 Clinician Programmer, showing an 'Invalid Device' message. Affected units have unique serial numbers and GTINs listed in the recall.
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Medtronic is recalling a limited number of Percept RC Implantable Neurostimulators (Model B35300) because they cannot communicate with the A610 Clinician Programmer, displaying an 'Invalid Device' message. This issue may prevent proper device management and could lead to incorrect programming or device malfunction.
The device fails to communicate with the A610 Clinician Programmer application, causing an 'Invalid Device' message. This prevents the user from properly managing the device settings, which could lead to incorrect programming or device malfunction if not addressed.
Patients with Medtronic Percept RC Implantable Neurostimulators (Model B35300) who use the A610 Clinician Programmer are likely affected. Those with the specific serial numbers or GTINs listed in the recall are at the highest risk.
Check if your device has the model number B35300 and the specific serial numbers or GTINs listed in the recall. The affected units include 12 distinct serial numbers across multiple GTINs.
Verify your device model is B35300 and matches the serial numbers or GTINs listed in the recall.
Medtronic recalls these specific Model B35300 devices because they cannot communicate with the A610 Clinician Programmer application, showing an 'Invalid Device' message.
Check if your device has the model number B35300 and the specific serial numbers or GTINs listed in the recall, which include 12 distinct serial numbers across multiple GTINs.
The recall does not specify a remedy, so contact Medtronic directly to discuss next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0206-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0206-2025 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.