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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.

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Ongoing Issue

Update to May 11 2023 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)

Click here for product performance reports for alternative devices. 

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At Risk Devices

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

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

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

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

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

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

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At Risk Devices

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

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

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

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

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

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

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

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Ongoing Issue

ADVISORY: Medtronic Medical Device Recall

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

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Ongoing Issue

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

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

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

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

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

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

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

ADVISORY: Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501)
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Resolved Issues

ADVISORY: Boston Scientific SICD VF Induction Anomaly

Note: Firmware update resolving the issue August 2017.

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Resolved Issues

ADVISORY: Boston Scientific Minute Ventilation Over-sensing Advisory

Note: Firmware update resolving the issue confirmed March 2019.

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Resolved Issues

ADVISORY: LivaNova DF-4 Ring Connection
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Ongoing Issue

ADVISORY: Nanostim Leadless II IDE/CAP
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Ongoing Issue

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

ADVISORY: TactiSys Quartz Equipment with Software Version 1.7.0
Ongoing Issue

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

ADVISORY: Boston Scientific S-ICD in-clinic Programmer

Risk of RF interference causing inappropriate in-clinic programming.

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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.

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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.

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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

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Resolved Issues

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

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

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

UPDATE: Cognis and Teligen ICDs
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Resolved Issues

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

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Resolved Issues

ADVISORY: Medtronic EnRhythm® and EnRhythm MRI Pacemakers
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