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CIED Recalls & Advisories

Resolved Issues

August 2019

ADVISORY: Boston Scientific SICD VF Induction Anomaly

Note: Firmware update resolving the issue August 2017.

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Resolved Issues

August 2019

ADVISORY: Boston Scientific Minute Ventilation Over-sensing Advisory

Note: Firmware update resolving the issue confirmed March 2019.

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Resolved Issues

August 2019

ADVISORY: LivaNova DF-4 Ring Connection
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At Risk Devices

August 2019

ADVISORY: Nanostim Leadless II IDE/CAP
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At Risk Devices

August 2019

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

April 2019

ADVISORY: TactiSys Quartz Equipment with Software Version 1.7.0
Ongoing Issue

January 2019

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
Resolved Issues

January 2017

ADVISORY: Boston Scientific S-ICD in-clinic Programmer

Risk of RF interference causing inappropriate in-clinic programming.

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At Risk Devices

October 2016

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.

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Ongoing Issue

October 2016

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.

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Resolved Issues

April 2016

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

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Resolved Issues

November 2015

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

November 2015

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

August 2012

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

July 2012

UPDATE: Cognis and Teligen ICDs
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Resolved Issues

December 2011

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

May 2010

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.

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Resolved Issues

February 2010

ADVISORY: Medtronic EnRhythm® and EnRhythm MRI Pacemakers
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