ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021
Device: Medtronic Reveal LINQ with TruRhythm Cardiac Monitoring Systems
TGA Reference: RC-2021-RN-01276-1
Australian Register of Therapeutic Goods (ARTG): 218791
Advisory grade TGA: Class II
(Class II recall action occurs when the product deficiency could cause illness, injury or result in mistreatment, but are not class I.)
ANZDACC Advisory Grade: Routine
ANZCDACC Safety Alert Notice March 21st 2021
Device:
Subset Biontronik Ilesto, Inventra, Iperia, Itrevia, Ilivia, Intica, Intica Neo ICDs and CRT-D implanted since 2013
TGA Reference: RC-2021-RN-00667-1
Advisory grade TGA: Class I
(Class I recall action occurs when the product deficiency is potentially life threatening or could cause serious risk to health)
ANZDACC Advisory Grade: Routine
Number of CIEDs affected in Australia and New Zealand:
Australia Approximately 2000
New Zealand Approximately 500
ANZCDACC Product Notification Notice 22nd November 2019
UPDATE: 4th of Feb 2021 – Updated text in purple.
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TGA Reference: RC-2019-RN-01641-1
Advisory grade TGA: TBA
ANZDACC Advisory Grade: Routine
Number of CIEDs affected in Australia and New Zealand: TBA
ANZCDACC Product Defect Correction Notice August 2019
Device:
ARTG:
ANZCDACC Safety Alert Notice 21 December 2020
Device:
ANZCDACC Advisory Notice 6th December 2020
Device: EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode
ANZCDACC Advisory Notice 6th December 2020
Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) all Implanted from May 2015 to December 2017
ANZCDACC Product Notification Notice 22nd November 2019
Device:
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ANZCDACC Advisory Notice 17th January 2019
Device: Programmer Software Update supporting the Micra Transcatheter Pacing System (TPS)
Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Application software 2491
