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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