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Inceptiv

Official notice

10 Jun 2025

CriticalHealth Canada

An official Health Canada notice concerns Inceptiv. Performing a switch device operation from the 97725 or 9772501 WENS using the A71300 SCS trialing app to transfer data (e.g. Patient and lead information) to a new implanted Inceptiv or Intellis Pro Implantable Neurostimulator (INS) results in the A71400 CP app crashing and the INS becoming unusable when the transfer involves a predefined legacy lead option selected in the app that uses the forward slash character "/". Recall start date: May 28, 2025 Published 2025-06-10.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77580

Official notice

2025-06-10

The hazard

Performing a switch device operation from the 97725 or 9772501 WENS using the A71300 SCS trialing app to transfer data (e.g. Patient and lead information) to a new implanted Inceptiv or Intellis Pro Implantable Neurostimulator (INS) results in the A71400 CP app crashing and the INS becoming unusable when the transfer involves a predefined legacy lead option selected in the app that uses the forward slash character "/". Recall start date: May 28, 2025

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77580

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Affected products

Product 1

Affected products - Inceptiv, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 977119

Risk / hazard

Performing a switch device operation from the 97725 or 9772501 WENS using the A71300 SCS trialing app to transfer data (e.g. Patient and lead information) to a new implanted Inceptiv or Intellis Pro Implantable Neurostimulator (INS) results in the A71400 CP app crashing and the INS becoming unusable when the transfer involves a predefined legacy lead option selected in the app that uses the forward slash character "/". Recall start date: May 28, 2025

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Inceptiv.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

77580

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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