Restore Clinician Programmer Application Software, model… recallZ-2657-2023 · Medtronic Neuromodulation · initiated Jul 17, 2020

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

Letters dated July 2020 and flagged as "URGENT: MEDICAL DEVICE CORRECTION RESTORE CLINICIAN PROGRAMMER APPLICATION SOFTWARE UPDATE Model A71100" were issued via USPS Priority First Class Mail on 7/17/2020. The letter provided an issue summary and informed the consignee the updated version of the A71100 application was now available for download and installation for resolving the issue. The consignee was to follow the instructions provided with the letter to update the application and if assistance was needed, contact information was provided for the Technical Services team support. Once the required update is made, the action will be tracked through the firm's mobile software deployment systems and no additional reply was needed from the consignee. The letter also explained patient risk, how to identify the issue, and conditions resulting in the issue. The letter was to be shared as appropriate with those in the consignee's organization who require the information.

Recall details

Recall number: Z-2657-2023
Status: Terminated
Initiated by the company: Jul 17, 2020
Posted by the FDA: Sep 29, 2023
Recalling firm: Medtronic Neuromodulation
Quantity: 2,408 devices
Product code: LGW
Distribution: Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

Product description

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

Code information (models, lots, serial numbers)

Version 1.0.4232, UDI-DI 00763000273668.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

N/A A71100
Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
2 recalls0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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