FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Recall number
- Z-2657-2023
- Recalling firm
- Medtronic Neuromodulation
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Status
- Terminated
- Initiated
- 2020-07-17
- Posted
- 2023-09-29
- Terminated
- 2024-09-27
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 2,408 devices
- Distribution
- Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
- Lot, serial or model codes
- Version 1.0.4232, UDI-DI 00763000273668.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28