FDA recall Z-0206-2025

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-09-24

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0206-2025