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

FDA device recall Z-0206-2025 · posted 2024-10-23 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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

Status

Open, Classified

Product code

MHY

Quantity affected

39 units

Distribution

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

Date initiated

2024-09-24

Date posted

2024-10-23

Location

Minneapolis, MN