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Health Canada Medical devices

Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds)

Issued September 15, 2023
Issue
Abott is informing customers of a rare potential for a bluetooth circuit component issue on subset of Neturino Implantable Cardioverter Defrbrillators (ICDs) and Cardiac Resynchronization Therapy Defribrilators (CRT-Ds) manufactured prior to April 2022. This issue has been associated with a risk of loss of bluetooth communication (and therefore a loss of remote monitoring), higher-than-normal current consumption, and reduced device longevity. Recall start date: August 21, 2023
Hazard description
Performance
Product
Product name
Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds)
Reference
ID
RA-74288