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Medtronic Neuromodulation recalls Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product U
Recalled January 20, 2021 · FDA recall Z-0860-2021 · Medtronic Neuromodulation
Hazard
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. · FDA Class II
Units
7960 downloads
Sold at
Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Description
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Product
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →