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CIED Recalls & Advisories

DISCLAIMER: Apart from official CHRS advisories or template letters, the CHRS does not necessarily endorse the views expressed in any of these external documents.

At Risk Devices

December 2023

Update to the June 2021 High Battery Impedance Advisory in INGENIOTM, VITALIOTM, and ADVANTIOTM dual chamber (DR) extended life (EL) pacemakers and INLIVENTM, INTUATM, and INVIVETM cardiac resynchronization therapy pacemakers (CRT-Ps)
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At Risk Devices

December 2023

Boston Scientific Model 2892 Software on Model 3120 ZOOM Programmers
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At Risk Devices

October 2023

Transient Sensing Behaviour, Boston Scientific S-ICD Models A209 and A219
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At Risk Devices

August 2023

ADVISORY: BLUETOOTH FUNCTION ON GALLANT™, NEUTRINO™, AND ENTRANT™ ICDs AND CRT-Ds MANUFACTURED PRIOR TO APRIL 2022
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At Risk Devices

June 2023

ADVISORY: 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)
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Ongoing Issue

August 2022

ADVISORY: Abbott Medical Device Recall SUBSET OF ASSURITY™ & ENDURITY™ PACEMAKER MODELS PM2172, PM2272

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At Risk Devices

July 2022

ADVISORY: Boston Scientific Model 2868 Software on Model 3120 ZOOM Programmers, When Used in Conjunction with Transvenous Defibrillators
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At Risk Devices

July 2022

ADVISORY: Potential for Intermittent-Reduced-Energy Shock Due in Medtronic Cobalt XT, Cobalt and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)
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At Risk Devices

July 2022

ADVISORY: LATITUDE™ Cybersecurity Update (“Apache Log4j” CVE-2021-44228)
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Resolved Issues

July 2022

ADVISORY: Battery Longevity Overestimates with The Merlin Patient Care System And Merlin.Net Remote Monitoring When Used With Accent/Anthem And Endurity/Assurity/Allure Family Of Pacemakers
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At Risk Devices

July 2022

ADVISORY: Abbott MerlinTM and MerlinTM2 Patient Care System (PCS) When used with GallantTM, NeutrinoTM NxT, EntrantTM devices
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Resolved Issues

July 2022

UPDATED ADVISORY: Premature Battery Depletion, Boston Scientific SICD Models A209 and A219.
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At Risk Devices

July 2022

VOLUNTARY MEDICAL DEVICE RECALL URGENT FOR A SUBSET OF ASSURITY™, AND ENDURITY™ PACEMAKERS

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Ongoing Issue

June 2021

ADVISORY: Medtronic Medical Device Recall

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

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Ongoing Issue

June 2021

ADVISORY: Boston Scientific ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 pacemakers and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps)
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Ongoing Issue

June 2021

ADVISORY: INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps)
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Ongoing Issue

March 2021

ADVISORY: Abbott Medical Device Recall

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

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Ongoing Issue

March 2021

ADVISORY: Potential premature battery depletion in a subset of Biotronik ICD and CRT-D devices (Idova, Iforia, Ilesto / Inventra, Iperia, Itrevia / Ilivia, Inlexa, Intica / Ilivia Neo, Intica Neo)
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Ongoing Issue

February 2021

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

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Ongoing Issue

February 2021

ADVISORY: Electromagnetic Interference (EMI) from Mobile Phones and Other Accessories with Incorporated Magnets
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Ongoing Issue

December 2020

ADVISORY: Boston Scientific: Electrical Overstress During Delivery of High-Voltage Therapy
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Ongoing Issue

December 2020

ADVISORY: Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501)
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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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Ongoing Issue

August 2019

ADVISORY: Nanostim Leadless II IDE/CAP
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Ongoing Issue

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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Ongoing Issue

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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