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Medtronic Neuromodulation recalls Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Recalled October 11, 2023 · FDA recall Z-2657-2023 · Medtronic Neuromodulation
Hazard
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. · FDA Class II
Units
2,408 devices
Sold at
Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Description
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.
Product
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →