Category: Device Alerts

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

ANZCDACC Advisory Notice 24^th December 2017

Device: Boston Scientific VALITUDE™ CRT-P Model U128, RESONATE™ CRT-D Model G447, MOMENTUM™ CRT-D Model G124, G125, G126, G128, AUTOGEN™ CRT-D Models G172, G173, G175, G177, G179 VISIONIST™ CRT-P Models U225, U226, U228, DYNAGEN™ CRT-D Models G151, G156, G158

ANZCDACC Advisory Notice 1st December 2017

Device: Information About Cybersecurity for Accent^TM/Anthem^TM/Accent MRI^TM/AccentST^TM/Allure^TM and Assurity MRI^TM and Assurity MRI^TM devices

ANZCDACC Advisory Notice 29^th November 2017

Device: Medtronic MyCareLink Remote Monitors: Models 24950 and 25000

Device: LivaNova (Formerly Sorin Group) Platinium ICDs and CRTDs