CIED Recalls &amp; Advisories

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

February 2021

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

Note: Firmware update resolving the issue August 2017.

ADVISORY: Boston Scientific Minute Ventilation Over-sensing Advisory

August 2019

Note: Firmware update resolving the issue confirmed March 2019.

ADVISORY: LivaNova DF-4 Ring Connection

August 2019

ADVISORY: Nanostim Leadless II IDE/CAP

August 2019

ADVISORY: Battery Malfunction, Boston Scientific First Generation Model 101 SICD

August 2019

ADVISORY: TactiSys Quartz Equipment with Software Version 1.7.0

April 2019

Company Information for Physician or Healthcare Professional - ENG

ADVISORY: Medtronic Pacemakers – risk of circuit error with loss of ventricular pacing output for a subgroup of Adapta, Versa, Sensia, Relia, Attesta and Sphera pacemakers

January 2019

ADVISORY: Boston Scientific S-ICD in-clinic Programmer

January 2017

Risk of RF interference causing inappropriate in-clinic programming.

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

October 2016

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

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™

October 2016

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.

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

April 2016

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

ADVISORY: InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P) Models 8042, 8042U

November 2015

ADVISORY: St-Jude Medical, Optisure™ Dual Coil HV Leads Model #LDA220, LDA220Q, LDA230Q, LDP220Q

November 2015

UPDATE: St. Jude Medical Riata and Riata ST High Voltage Leads

August 2012

UPDATE: Cognis and Teligen ICDs

July 2012

ADVISORY: St. Jude Medical Riata and Riata ST High Voltage Leads

December 2011

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

May 2010

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.

ADVISORY: Medtronic EnRhythm® and EnRhythm MRI Pacemakers

February 2010