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Inceptiv — recall 77580

Health Canada — Medical Devices · Canada · 2025-06-10 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 77580
Date of alert: 2025-06-10
Country / jurisdiction: Canada
Risk level: Type II
Risk type: recall
Product category: Neurology
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/inceptiv

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Inceptiv — recall 77580

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