Medtronic Neuromodulation: Medical Device Recall in 2023 - (Recall #: Z-2657-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Product Classification:

Class II

Date Initiated: July 17, 2020

Date Posted: October 11, 2023

Recall Number: Z-2657-2023

Event ID: 92798

Reason for Recall:

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

Status: Terminated

Product Quantity: 2,408 devices

Code Information:

Version 1.0.4232, UDI-DI 00763000273668.

Distribution Pattern:

Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated