HIGH

Medtronic Recalls Clinician Programmer App Over High-Risk Software Issue

Medtronic Neuromodulation recalled 7,667 Clinician Programmer Applications on November 20, 2025. A software issue may prevent patients from resuming therapy, leading to a recurrence of pain symptoms. Affected models include A71100 and associated tablets.

Quick Facts at a Glance

Recall Date
November 20, 2025
Hazard Level
HIGH
Brand
Medtronic Neuromodulation
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medtronic Neuromodulation or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Restore Clinician Programmer Application is used to manage therapy for patients with implanted neurostimulation devices. Patients rely on this application for pain relief and therapy management.

Why This Is Dangerous

The software issue prevents users from clearing a Device Reset message, which can halt therapy. This results in a return of pain symptoms for patients dependent on the device for relief.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects patients' ability to manage pain effectively, potentially leading to increased discomfort and the need for further medical intervention.

Practical Guidance

How to identify if yours is affected

  1. Check if you have the Restore Clinician Programmer Application Model A71100 or related models.
  2. Verify the software version; all versions prior to v.1.0.4489 are affected.
  3. Contact your healthcare provider for confirmation of device status.

Where to find product info

Serial numbers and version information can usually be found in the application settings or on the device itself.

What timeline to expect

Expect a timeline of 4-6 weeks for resolution processes, including potential replacements or refunds.

If the manufacturer is unresponsive

  • Document your communications with the manufacturer or healthcare provider.
  • Follow up via phone or email if you do not receive timely responses.
  • Consider reporting the issue to regulatory bodies if the company remains unresponsive.

How to prevent similar issues

  • Inquire about software updates and recalls when purchasing medical devices.
  • Choose devices with strong customer support and warranty options.
  • Stay informed about potential recalls through official health channels.

Documentation advice

Keep copies of all correspondence, receipts, and documentation related to the recall for your records.

Product Details

The recall affects the Restore Clinician Programmer Application (Model A71100) used with models CT900A, CT900B, CT900C, CT900D, CT900E, and CT900F. The devices were distributed worldwide, including the U.S., Canada, and various countries in Europe and Asia.

Key Facts

  • Recall date: November 20, 2025
  • Total quantity recalled: 7,667 devices
  • Class II recall due to high hazard level
  • Devices distributed worldwide
  • Affected models: CT900A, CT900B, CT900C, CT900D, CT900E, CT900F

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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