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Medtronic restore™ clinician programmer application
Official notice
28 Nov 2025
An official Health Canada notice concerns Medtronic restore™ clinician programmer application. Medtronic is initiating a medical device recall (notification) to notify consignees of a potential for a software issue that may occur when attempting to clear a device reset message using the model A71100 Restore Clinician Programmer application (CP App). The A71100 CP App is used to program the restore family of Spinal Cord Stimulation implantable neurostimulators (INS). A device reset can occur for a variety of reasons, including when the INS has an overdischarged battery, which is normally cleared during a programming session. In rare cases, the device reset message cannot be cleared and may result in the inability to resume therapy resulting in the patient experiencing a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS to resume therapy. Published 2025-11-28.
What to do now
Contact the manufacturer if you require additional information.
Recall number
81294
Official notice
2025-11-28
The hazard
The hazard
Medtronic is initiating a medical device recall (notification) to notify consignees of a potential for a software issue that may occur when attempting to clear a device reset message using the model A71100 Restore Clinician Programmer application (CP App). The A71100 CP App is used to program the restore family of Spinal Cord Stimulation implantable neurostimulators (INS). A device reset can occur for a variety of reasons, including when the INS has an overdischarged battery, which is normally cleared during a programming session. In rare cases, the device reset message cannot be cleared and may result in the inability to resume therapy resulting in the patient experiencing a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS to resume therapy.
How to check if you're affected
How to check if you're affected
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The source does not list specific retailers. See the official notice for where affected products were sold.
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Brand: Medtronic, Medtronic Restore™ Clinician Programmer Application.
Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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