Video presentations from the 2019 ASM can be viewed at the following location:
Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Software 2491 (17 Jan 2019)
Update required to display correct longevity estimate for Micra TPS
Device: Programmer Software Update supporting the Micra Transcatheter Pacing System (TPS): Medtronic 2090 Carelink Programmer, 29901 Encore Programmer, Carelink Network Application software 2491
ANZCDACC Product Defect Correction Notice 17th Jan 2019
ARTG: 116038 & 213024
TGA Reference: RC-2019-RN-00079-1
Medtronic Adapta DR (Jan 2019)
If error occurs, device will withhold pacing until a VS detected
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.
TGA Reference: RC-2019-RN-00080-1
Cameron Health Sub-Q RX Model 1010 S-ICD (Jan 2019)
Shortened replacement interval after ERI
Device: Cameron Health Incorporated (Boston Scientific) SQ-RX Model 1010 (First generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD))
ANZCACC Advisory Notice 18th January 2019
ARTG: 219499 (Discontinued)
TGA Reference: RC-2018-RN-01427-1
Medtronic Carelink 2090, Carelink Encore 29901/29901A programmers (18Jan2019)
Vulnerable to being hacked when connected to internet for software upgrades
Device: Medtronic Carelink 2090 and the Carelink Encore 29901/29901A programmers (All serial numbers)
ANZCDACC Advisory Notice 18th January 2019
TGA Reference: RC-2018-RN-01351-1
Boston Scientific VALITUDE™ CRT-P, VISIONIST™ CRT-P, ACCOLADE™ Pacemakers, PROPONENT™ Pacemakers (24 Dec 2017)
Intermittent over sensing of Minute Ventilation sensor causing periods of pacing inhibition.
ANZCDACC Advisory Notice 24th 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
TGA Reference: RC-2017-RN01509-1
Boston Scientific: VALITUDE™ CRT-P, RESONATE™ CRT-D, MOMENTUM™ CRT-D, AUTOGEN™ CRT-D, VISIONIST™ CRT-P, DYNAGEN™ CRT-D(24Dec2017)
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
TGA Reference: RC-2017-RN-01510-1
St Jude Cybersecurity for Accent ™, Anthem™, Accent MRI™, AccentST™ Allure™ and Assurity MRI™ and Assurity MRI™ devices (Dec 2017)
Software upgrade info
ANZCDACC Advisory Notice 1 December 2017
Device: Information About Cybersecurity for AccentTM AnthemTM Accent MRITM AccentSTTM AllureTM and Assurity MRITM and Assurity MRITM devices
TGA Reference: RC-2017-RN-01403-1
Medtronic MyCareLink Remote Monitors: Models 24950 and 25000 (29Nov2017)
If patient has more than one CIED, they may not be able to send data or unintentionally from the other
Medtronic MyCareLink Remote Monitors: Models 24950 and 25000
ANZCDACC Advisory Notice 29th November 2017
TGA Reference: RC-2017-RN-01009-1
Boston Scientific: EMBLEM™ S-ICDs Models A209 and A219 and SQ-RXTM S-ICDs Model 1010 (July 2017)
Device: EMBLEM™ S-ICDs (Models A209 and A219) and SQ-RXTM S-ICDs (Model 1010)
ANZCDACC Advisory Notice 14th July 2017
TGA Ref: RC-2017-RN-00830-1