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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medtronic Neuromodulation
- Product type
- Clinician Programmer Application
- Model numbers
- CP App: UDI-DI 00763000273668 all software versions prior to v.1.0.4489 are affected The implanted devices are not affected.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 20, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check if you have the Restore Clinician Programmer Application Model A71100 or related models.
- Verify the software version; all versions prior to v.1.0.4489 are affected.
- 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.
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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
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Safety Guide
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