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.
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.
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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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.
A software issue causes a Device Reset message that cannot be cleared. This problem may prevent therapy resumption, resulting in patients experiencing underlying pain symptoms.
No specific incident counts were reported. However, the inability to resume therapy poses a high risk to patients depending on the device for pain management.
Patients and healthcare providers must stop using the device immediately. Follow the manufacturer’s recall instructions and contact Medtronic Neuromodulation for guidance.
For more information, contact Medtronic Neuromodulation or visit their recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0996-2026.
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