Z-0860-2021Class II

Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 -

Name: Z-0860-2021 Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 -
Creator: Medtronic Neuromodulation
Published: 2020-11-12
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2020-11-12 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in... on 2020-11-12. FDA classified it as Class II and gives the reason as "A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0860-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-12
Posted: 2021-01-14
Recalling firm: Medtronic Neuromodulation
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Medtronic notified the first consignee by letter on 11/12/2020 with a confirmation of their complaint and request to perform a correction to the device which put the device in a factory-reset state and restore functionality to allow programming and continued therapy. On 17 Dec 2020, Medtronic will begin issuing an Urgent Medical Device Correction notification to physicians regarding this validation error and providing instructions on the impact and appropriate mitigating actions if this issue presents.
Quantity in commerce: 7960 downloads
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
Product codes and lots: Software version 1.3.80

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0860-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0860-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-20	2021-01-14

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)