Company: Medtronic Neuromodulation
Date of Enforcement Report: 1/20/2021
Class II
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.
Recall Number: Z-0860-2021
REASON
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
RECALLING FIRM/MANUFACTURER
Medtronic Neuromodulation on 11/12/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7960 downloads
DISTRIBUTION
U.S. Nationwide and International