Medtronic Neuromodulation: Medical Device Recall in 2021 - (Recall #: Z-0860-2021)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2021.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: November 12, 2020
Date Posted: January 20, 2021
Recall Number: Z-0860-2021
Event ID: 86872
Reason for Recall:
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Status: Ongoing
Product Quantity: 7960 downloads
Code Information:
Software version 1.3.80
Distribution Pattern:
Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Voluntary or Mandated:
Voluntary: Firm initiated