Z-0860-2021 Class II Ongoing
FDA device recall Z-0860-2021 was initiated by Medtronic Neuromodulation on Nov 12, 2020 and is designated Class II. Reason for recall: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device. The recall status is ongoing. Affected quantity: 7960 downloads.
Recall details
- Product Type
- Devices
- Report Date
- Jan 20, 2021
- Initiation Date
- Nov 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7960 downloads
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.
Reason for recall
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Distribution pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Code information
Software version 1.3.80
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0860-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026