Home / Recalls / Medical Devices
Medtronic Neuromodulation recalls Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Recalled October 30, 2024 · FDA recall Z-0206-2025 · Medtronic Neuromodulation
Hazard
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. · FDA Class II
Units
39 units
Sold at
International distribution to the countries of Germany, UK, and Israel.
Description
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.
Product
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →