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Open, Classified

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

FDA Recall Z-0206-2025 · Posted 2024-10-23

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeMHY
Date Initiated2024-09-24
Product Quantity39 units

Reason for 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.

Firm Action

Medtronic neuromodulation issued an URGENT MEDICAL DEVICE RECALL notice to its consignees of 09/24/2024 via letter. The notice explained the issue, potential risk, and requested the affected devices in stock be returned. The notice is to be shared with those to whom the device was distributed. If the device has been implanted, the consignee was directed to contact their Medtronic Representative to determine if there are additional steps that may establish communication with the INS. On 07-Oct-24 and 08-Oct-24, a Medtronic representative successfully performed an update using a manufacturing software tool to reestablish communication to the affected devices. Consignees were provided a consignee notification regarding this action.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the countries of Germany, UK, and Israel.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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