Public recall detail

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

2023-09-15

medium
Recall Safety notice
Quick summary

Quick summary: Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds). Date: 2023-09-15.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Neutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds). Date: 2023-09-15.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSt. Jude Medical, Cardiac Rhythm Management Division
ProductNeutrino NxT Implantable Cardioverter Defibrilator (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-Ds)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74288

Affected products

ProductNeutrino NxT VR Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelCDVRA600Q
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNeutrino NxT VR Implantable Cardioverter Defibrillator
ProductNeutrino NxT DR Implantable Cardioverter Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelCDDRA600Q
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNeutrino NxT DR Implantable Cardioverter Defibrillator
ProductNeutrino NxT HF Cardiac Resynchronization Therapy Defibrillator
LotMore than 10 numbers, contact manufacturer.
ModelCDHFA600Q
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNeutrino NxT HF Cardiac Resynchronization Therapy Defibrillator

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesSt. Jude Medical, Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, United States, 91342
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74288
Background{}
CompaniesSt. Jude Medical, Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, United States, 91342
AudiencesHealthcare
Source updated2023-09-15

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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