CIED Recalls & Advisories

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CHRS: Advisories
At Risk Devices

Potential for Intermittent Reduced-Energy or No-Energy High Voltage therapy in a subset of Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Medtronic has released a software update for the SmartSync tablet programmer.

This update aligns the nominal settings and programming screens with the programming recommendations from the May 2023 communication (listed below). As a result of this update, devices interrogated with an updated SmartSync tablet programmer (device application software 2.1.0 or higher) are no longer considered to be in scope of this advisory.

Updates to the CareLink Encore™ and CareLink™ 2090 programmers will be released at a future date.

Please read the attached document for further details.

Ongoing Issue

ADVISORY: Medtronic Medical Device Recall

REVEAL LINQ Insertable Cardiac monitor (LNQ11)
LINQ II Insertable Cardiac monitor (LNQ22)

Ongoing Issue

ADVISORY: Abbott Medical Device Recall

ASSURITY™ AND ENDURITY™ PACEMAKERS MODELS PM1160, PM1172, PM1240, PM1272, PM2160, PM2172, PM2240, PM2260, PM2272

Ongoing Issue

ADVISORY: Potential for Premature Battery Depletion in a Subset of Medtronic ICD and CRT-D Devices

Potential for Premature Battery Depletion in a Subset of Medtronic ICD and CRT-D Devices: Claria MRI™/Amplia MRI™/Compia MRI™/Viva™/Brava CRT-Ds™/Visia AF™/Visia AF MRI™/Evera™/Evera MRI™ ICDs

Resolved Issues

ADVISORY: Boston Scientific S-ICD in-clinic Programmer

Risk of RF interference causing inappropriate in-clinic programming.

Ongoing Issue

ADVISORY: Battery Malfunction, St. Jude Medical NanoStim™ Leadless Cardiac Pacemaker System

This advisory describes a battery malfunction with the St. NanoStim™ Leadless Cardiac Pacemaker (LCP) system.

Ongoing Issue

ADVISORY: Premature Battery Depletion with St. Jude Medical ICD and CRT-D devices manufactured before May 23, 2015. Affected models include Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™

This advisory relates to an increased risk of premature, and possibly sudden, battery depletion with the St. Jude Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra ICDs manufactured before May 23, 2015.

Devices manufactured after May 23, 2015 are not affected by this advisory.

Resolved Issues

ADVISORY: 37 Units of Ellipse™ Implantable Cardioverter Defibrillator (None in Canada)

Models Affected:
CD1411-36Q / CD2411-36C / CD2377-36QC
CD1411-36C / CD1377-36QC / CD2377-36C
CD2411-36Q / CD1377-36C

Resolved Issues

ADVISORY: Medtronic Consulta CRTD, Secura VR/DR, Maximo II CRTD and Maximo II VR/DR ICD

Delay or loss of high voltage therapies may occur subsequent to the rare circumstance of 3 “simultaneous” events, which can be corrected with an anticipated software release.