Boston Scientific EMBLEM™ S-ICDs (Models A209 and A219) Implanted – May 2015 to Dec 2017 (6 December 2020)

Over time a pathway may develop in header that allows moisture ingress, enabling a shorting condition to occur during delivery of HV therapy

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

6 December 2020

 Advisory grade TGA: TBA


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Boston Scientific Model A209 Emblem™ S-ICDs and Model A219 Emblem MRI™ S-ICDs (August 2019)

May have compromised performance of an electrical component causing accelerated battery depletion

ANZCDACC Product Defect Correction Notice August 2019


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


  1. 260382
  2. 286705

TGA Reference: RC-2019-RN-01242-1

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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

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Medtronic Adapta DR (Jan 2019)

If error occurs, device will withhold pacing until a VS detected

ANZCDACC Advisory Notice 24th January 2019

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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

LivaNova Platinium ICD and CRTD (July 2018)

ANZCDACC Advisory Notice 2nd August 2018

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LivaNova:  Limited subset of Platinium ICD and CRTD

(Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540, Platinium CRT-D 1711, Platinium CRT-D 1741, Platinium SONR CRT-D 1811, Platinium SONR CRT-D 1841.)

Serial numbers of affected devices in Australia: 629DL05C, 650DL087, 638DD149, 639DD140, 639DD15E, 624DF096

TGA Reference: RC-2018-RN-00929-1

Australian Register of Therapeutic Goods (ARTG): 282817, 282816, 282818, 282819, 282820, 282821, 282822, 282823 respectively.

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

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