Lower risk Medical device recall · FDA · Published November 20, 2025

Medtronic Restore CP App Model A71100 Software Issue: Rare Therapy Disruption Risk

Medtronic recalls Restore Clinician Programmer App Model A71100 software versions before v.1.0.4489. Rare device reset issues may cause pain recurrence. Affected users should contact Medtronic for repair or replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0996-2026Medical device Medtronic Neuromodulation ›

Lower-risk recall

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Take action

Contact the company

Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568

✎ GovInfoNow plain-language explainer

Medtronic is recalling the Restore Clinician Programmer Application (CP App) Model A71100 software versions older than v.1.0.4489. This software issue can rarely cause therapy interruptions and pain recurrence in patients. The recall does not affect the implanted devices themselves. Read more at govinfonow.com/recall/50635-medtronic-restore-cp-app-model-a71100-software-issue-rare-therapy.

Source Summary by GovInfoNow · govinfonow.com/recall/50635-medtronic-restore-cp-app-model-a71100-software-issue-rare-therapy · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0996-2026

Cite this page

“Medtronic Restore CP App Model A71100 Software Issue: Rare Therapy Disruption Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50635-medtronic-restore-cp-app-model-a71100-software-issue-rare-therapy. Based on FDA recall #Z-0996-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2026%22&limit=1).

The FDA announced on Nov. 20, 2025, that Medtronic Neuromodulation is recalling the Restore Clinician Programmer Application (CP App), Model A71100, due to a software issue preventing users from clearing a Device Reset message. This defect can result in an inability to resume therapy and recurrence of pain symptoms. The recall affects all software versions prior to v.1.0.4489.

How to tell if you have it

Restore Clinician Programmer Application (CP App), Model A71100
CT900A PROG CT900A CLINICIAN TABLET US
CT900B PROG CT900B CLINICIAN TABLET EU -UK
CT900C PROG CT900C CLINICIAN TABLET UK
CT900D PROG CT900D CLINICIAN TABLET GLOBAL
CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG
CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
CP App: UDI-DI 00763000273668

The hazard

A software issue causes a Device Reset message displayed on the app to be unable to be cleared. In rare cases, this results in an inability to resume therapy, and the patient experiences a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Context

GovInfoNow's records show Medtronic Neuromodulation has 45 other recalls on record since 2017-08-09. Other recent recalls of similar products include Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (2026-05-13), Medtronic SynchroMed Flex Infusion Software Issue: Steps May Not Program Correctly (2026-04-08), and Medtronic Vanta CP App Software Recall: Risk of Prolonged Surgery (2025-12-03). Other recent recalls of similar products include IntelePACS Software Update Causes Clinical Data Loss - Recall (2025-10-17), Fresenius Medical Care 5008X CAREsystem Recall: Software Anomalies Risk Treatment Stop (2025-10-25), and Elekta MOSAIQ Oncology System Software Recall: Treatment Plan Loading Risk (2026-05-21).

How to tell if you have this one

Check if your Restore CP App is version older than v.1.0.4489. The affected models are used with CT900A, CT900B, CT900C, CT900D, or CT900E programmers. The UDI-DI number 00763000273668 identifies the affected software.

Brand
Medtronic Neuromodulation
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your CP App version is older than v.1.0.4489 by checking the app settings or documentation.
Contact Medtronic
Reach out to Medtronic for repair or replacement of the affected software version.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic,…” 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 41 days after the firm started it.

Nov 20, 2025Firm started the recall
Dec 23, 2025FDA classified it Class II
Dec 31, 2025Published in FDA’s Enforcement Report

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

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Keep exploring

More Medtronic Neuromodulation recalls

Link to this recall

<a href="https://govinfonow.com/recall/50635-medtronic-restore-cp-app-model-a71100-software-issue-rare-therapy">Medtronic Restore CP App Model A71100 Software Issue: Rare Therapy Disruption Risk (GovInfoNow)</a>

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-0996-2026 (November 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0996-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.