Restore Clinician Programmer (Medtronic) - Software Compatibility Issue (2020)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
Version 1.0.4232, UDI-DI 00763000273668.
Products Sold
Version 1.0.4232, UDI-DI 00763000273668.
Medtronic Neuromodulation is recalling Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neuro due to The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinici. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026