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Neutrino nxt implantable cardioverter defibrilator (icds) and cardiac resynchronization therapy defibrillator (crt-ds)

Official notice

15 Sept 2023

MediumHealth Canada

An official Health Canada notice concerns Neutrino nxt implantable cardioverter defibrilator (icds) and cardiac resynchronization therapy defibrillator (crt-ds). 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 Published 2023-09-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74288

Official notice

2023-09-15

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74288

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Affected products

Product 1

Affected products - Neutrino NxT VR Implantable Cardioverter Defibrillator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - CDVRA600Q

Product 2

Affected products - Neutrino NxT DR Implantable Cardioverter Defibrillator, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - CDDRA600Q

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: St Jude Medical Cardiac Rhythm Management Division, Neutrino Nxt Implantable Cardioverter Defibrilator And Cardiac Resynchronization Therapy Defibrillator.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74288

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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