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Health Canada Medical devices

Vanta With Adaptivestim Technology

Issued June 22, 2023
Issue
Vanta Implantable Neurostimulator (INS) may malfunction after a cardioversion or defrbrillation procedure. The damage/malfunction to the device may no longer allow it to provide therapy or communicate with applications, resulting in a loss of stimulation and the need for an unanticipated surgery to explant/replace the INS. Recall start date : June 6, 2023
Hazard description
Performance
Product
Product name
Vanta With Adaptivestim Technology
Reference
ID
RA-73868