RecallRadar

FDA Device recall Z-2657-2023

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

On 2023-10-11 the FDA classified a Class II recall of Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators by Medtronic Neuromodulation, citing the original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software result….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2657-2023
ClassificationClass II
Statusterminated
Initiated2020-07-17
Published2023-10-11
Last updated2026-09-13 11:56 UTC
CompanyMedtronic Neuromodulation
DistributionUS

Product

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

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.

Identifiers

code_infoVersion 1.0.4232, UDI-DI 00763000273668.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2657-2023%22

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