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Medtronic restore™ clinician programmer application

Official notice

28 Nov 2025

Last checked

28 Nov 2025

Medium riskHealth Canada
Watch Medtronic

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

81294

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Affected products

Product 1

Affected products - Restore™ Clinician Programmer Application, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - A71100

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Medtronic, Medtronic Restore™ Clinician Programmer Application

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Medtronic Restore™ Clinician Programmer Application.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81294

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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