Health product recall

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

Last updated

Summary

Product
Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Neutrino NxT VR Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

CDVRA600Q

Neutrino NxT DR Implantable Cardioverter Defibrillator

More than 10 numbers, contact manufacturer.

CDDRA600Q

Neutrino NxT HF Cardiac Resynchronization Therapy Defibrillator

More than 10 numbers, contact manufacturer.

CDHFA600Q

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

St. Jude Medical, Cardiac Rhythm Management Division

15900 Valley View Court, Sylmar, California, United States, 91342

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74288

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