Reported Oct 11, 2023 · Terminated

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

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Lot codes and dates
    • Version 1.0.4232
    • UDI-DI 00763000273668
Amount recalled
2,408 devices

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 27, 2024 · Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.