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Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac… — recall 74288

Health Canada — Medical Devices · Canada · 2023-09-15 · Type II

As described by Health Canada — Medical Devices: Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds)

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Agency
Health Canada — Medical Devices
Recall identifier
74288
Date of alert
2023-09-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/neutrino-nxt-implantable-cardi

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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