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Lower risk Medical device recall · FDA · Published November 12, 2020

Medtronic Intellis Spinal Cord Stimulator Software Issue: Cannot Program Device

Medtronic recalls Intellis Spinal Cord Stimulator model A710 software version 1.3.80 due to inability to program the implantable neurostimulation device. Affected users should contact Medtronic for assistance.

🇺🇸 FDA recall #Z-0860-2021Medical deviceMedtronic ›
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Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

Medtronic is recalling the Intellis Spinal Cord Stimulator model A710 with software version 1.3.80 because it can't be programmed properly. This affects clinicians who use the device for pain therapy. If you have this model, contact Medtronic for help. Read more at govinfonow.com/recall/63926-medtronic-intellis-spinal-cord-stimulator-software-issue-cannot-program-device.

Source Summary by GovInfoNow · govinfonow.com/recall/63926-medtronic-intellis-spinal-cord-stimulator-software-issue-cannot-program-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0860-2021

Cite this page

“Medtronic Intellis Spinal Cord Stimulator Software Issue: Cannot Program Device.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63926-medtronic-intellis-spinal-cord-stimulator-software-issue-cannot-program-device. Based on FDA recall #Z-0860-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0860-2021%22&limit=1).

The FDA announced on November 12, 2020, that Medtronic Neuromodulation is recalling the Intellis Spinal Cord Stimulator Clinical Programmer application version 1.3.80 due to a software issue preventing device programming. The agency issued recall number Z-0860-2021 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Medtronic
  • Product: Intellis Spinal Cord Stimulator Clinical Programmer application version 1.3.80
  • Model Number: A710

The hazard

According to the FDA, the A710 Intillis Clinician Application contains a software issue that can result in the inability to program the Intillis implantable neurostimulation device. The recall affects 7,960 downloads distributed worldwide, including in the United States, Canada, Latin America, Asia Pacific, Japan, China, and European regions.

Context

GovInfoNow's records show Medtronic Neuromodulation has 45 other recalls on record since August 9, 2017. Other recent recalls include the Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (May 13, 2026), the SynchroMed Flex Infusion Software Issue (April 8, 2026), and the Vanta CP App Software Recall (December 3, 2025).

How to tell if you have this one

Check if your device has the model number A710 and software version 1.3.80. This is used by clinicians for programming the spinal cord stimulator in pain therapy.

  • Brand
    Medtronic
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact Medtronic

    Reach out to Medtronic for assistance with the software issue and possible updates.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 12, 202012. FDA classified it Class II: Jan 14, 202123. Published in FDA’s Enforcement Report: Jan 20, 2021320202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0860-2021 (November 12, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0860-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA