Category: Device Alerts

ANZCDACC Safety Alert Notice 21 December 2020

Device:

1. Model A209 EMBLEM ^TM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)
2. Model A219 EMBLEM MRI Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs)

 

ANZCDACC Advisory Notice 6^th December 2020

Device:  EMBLEM™ S-ICD Subcutaneous Electrode (Model 3501) current model S-ICD lead/electrode

ANZCDACC Advisory Notice 6^th December 2020

Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) (Models A209 and A219) all Implanted from May 2015 to December 2017

ANZCDACC Advisory Notice 6^th December 2020

Device:  Medtronic Cobalt™ and Crome™ ICD and CRT-D

ANZCDACC Product Notification Notice 22^nd 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

 

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

ANZCDACC Advisory Notice 24th January 2019

Device: Medtronic Adapta DR: Model numbers affected

Affected Model numbers	ARTG
ADDR01	125076
ADDR03	125077
ADDR06	125078
ADDRL1	125084
ADDRS1	125085
ADVDD01	125080

Not all Adapta devices are affected by this recall. Patients and clinicians may determine if a specific device is affected by looking up the serial number of Medtronic’s Product Performance website.

ANZCDACC Advisory Notice 18th January 2019

Device: Cameron Health Incorporated (Boston Scientific) SQ-RX Model 1010 (First generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD))

ANZCDACC Advisory Notice 18th January 2019

Device: Medtronic Carelink 2090 and the Carelink Encore 29901/29901A programmers (All serial numbers)

ANZCDACC Advisory Notice 24^th December 2017

Device: Boston Scientific VALITUDE™ CRT-P Model U128, VISIONIST™ CRT-P Models U225, U226, U228, ACCOLADE™ Pacemakers Models L310, L311, L331,  PROPONENT™ Pacemakers Models L210, L211, L231