Medtronic Neuromodulation: Medical Device Recall in 2024 - (Recall #: Z-0206-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 24, 2024

Date Posted: October 30, 2024

Recall Number: Z-0206-2025

Event ID: 95489

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.

Status: Ongoing

Product Quantity: 39 units

Code Information:

GTIN 00763000813468, Serial Numbers: NND504236H, NND504252H; GTIN 00763000813475, Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; GTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H; GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H; GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated