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

Recall date

September 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0206-2025

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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