Class II

Medical Device Recall: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

Medtronic Neuromodulation · September 24, 2024

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.

Distribution

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

Quantity Affected

39 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0206-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.