ANZCDACC Product Defect Correction and Implant Hazard Alert June 2021

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

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

ANZCDACC Product Notification Notice 22nd November 2019

UPDATE: 4th of Feb 2021 – Updated text in purple.

Device:

Product ARTG
Claria MRI™ CRT-Ds
280183; 280186 ; 281607; 281608
Amplia MRI™ CRT-Ds
280182; 280184 ; 281606
Compia MRI™ CRT-Ds
280181 ; 280185
Viva™ CRT-Ds
203210 ; 203211; 203212; 203840; 219221; 219222; 230204
Brava™ CRT-Ds
219220
Visia AF™ ICDs
280351; 280352; 280353
Visia AF MRI™ ICDs
280354; 280355; 282960; 282961
Evera™ ICDs
206324; 208024; 208025; 208026; 208027; 208028; 208029; 208030
Evera MRI™ ICDs
208030; 230019; 230020; 230021; 230022; 281609; 281610; 281611; 281612
Primo MRI™ ICDs
312640 ; 312641; 312642; 312643
Mirro MRI ™ ICDs
Not sold in Australia

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 Notification Notice 22nd November 2019

ANZCDACC Product Notification Notice 22nd November 2019

Device:

Product ARTG
Claria MRI™ CRT-Ds
280183; 280186 ; 281607; 281608
Amplia MRI™ CRT-Ds
280182; 280184 ; 281606
Compia MRI™ CRT-Ds
280181 ; 280185
Viva™ CRT-Ds
203210 ; 203211; 203212; 203840; 219221; 219222; 230204
Brava™ CRT-Ds
219220
Visia AF™ ICDs
280351; 280352; 280353
Visia AF MRI™ ICDs
280354; 280355; 282960; 282961
Evera™ ICDs
206324; 208024; 208025; 208026; 208027; 208028; 208029; 208030
Evera MRI™ ICDs
208030; 230019; 230020; 230021; 230022; 281609; 281610; 281611; 281612
Primo MRI™ ICDs
312640 ; 312641; 312642; 312643
Mirro MRI ™ ICDs
Not sold in Australia

 

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