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

FDA device recall Z-2657-2023 · posted 2023-09-29 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LGW

Quantity affected

2,408 devices

Distribution

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

Date initiated

2020-07-17

Date posted

2023-09-29

Date terminated

2024-09-27

Location

Minneapolis, MN