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 1.0.4232UDI-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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