Medical devices and IVDs: Suspensions from the ARTG

17 October 2018

Following a review by the TGA, medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989.

Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.

If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any related safety alerts will appear under 'Further information'.

The reasons for a suspension are stated in the database under 'Grounds for suspension'.

The heading 'Decision status' provides updated information about a suspension, for example, a decision to extend the suspension, or information about any decision to revoke a suspension decision. It will not appear in every entry.

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Medical devices and IVD suspensions

Displaying 1 - 25 of 54

2018

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Paediatric arterial cannula with 135 degree tip angle, collar, wire reinforcement and movable suture ring

ARTG number: 157871

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act.

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Arterial paediatric cannula with 135 degree tip angle with collar and wire reinforcement

ARTG number: 157870

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Arterial aortic cannula straight tip with collar with connector

ARTG number: 157818

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Paediatric venous cannula with 90 degrees tip angle with wire reinforcement

ARTG number: 157817

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Paediatric venous cannula with 90 degrees tip angle with wire reinforcement and collar

ARTG number: 157816

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Cardioplegia coronary perfusion cannula

ARTG number: 155615

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Arterial aortic cannula

ARTG number: 155613

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 11 Aug 2018

Suspension end date: 10 Apr 2019

LivaNova Australia Pty Ltd

Product name/ARTG reference: Highflow venous cannula

ARTG number: 155612

Type of regulatory action: Extension of the period of suspension from the ARTG for a further six month period under section 41GC of the Act

Grounds for extension of the suspension: The ARTG entries were suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure. The period of suspension has been extended as the manufacturer has taken steps to remove the grounds for cancelling the Devices.

Suspension start date: 5 Apr 2018

Suspension end date: 4 Apr 2019

Paragon Healthcare Pty Ltd

Product name/ARTG reference: Heat exchanger, heart-lung bypass

ARTG number: 135587

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling this ARTG entry, in accordance with subsection 41GN(1)(b) of the Act. The suspension from the ARTG was effective on 5 April 2018 for a period of six months.

Further information:

Summary of change to conditions: A decision to extend the suspension period for an additional 6 months was made in accordance with subsection 41GC(3) of the Act on 5 October 2018.

Suspension start date: 3 Apr 2018

Suspension end date: 3 Oct 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Emobolisation Device w/out tip

ARTG number: 281033

Type of regulatory action: Extension of suspension from the ARTG under s.41GC

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information:

Revocation of suspension effective 22 May 2018.

Revocation of suspension from the ARTG under s.41GD.

Under subsection 41GD; the grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b) no longer apply.

Suspension start date: 3 Apr 2018

Suspension end date: 3 Oct 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Embolisation Device with tip

ARTG number: 281030

Type of regulatory action: Extension of suspension from the ARTG under s.41GC

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information:

Revocation of suspension effective 22 May 2018.

Revocation of suspension from the ARTG under s.41GD.

Under subsection 41GD; the grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b) no longer apply.

Suspension start date: 5 Feb 2018

Suspension end date: 4 Aug 2018

Medtronic Australasia Pty Ltd

Product name/ARTG reference: Puritan Bennett 980 Series Ventilator

ARTG number: 221416

Type of regulatory action: Suspended from the ARTG for a 6 month period under section 41GN(1)(a)(i) of the Act

Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register.

Suspension start date: 5 Feb 2018

Suspension end date: 4 Aug 2018

Medtronic Australasia Pty Ltd

Product name/ARTG reference: Puritan Bennett 980 Series Ventilator

ARTG number: 221416

Type of regulatory action: Suspended from the ARTG for a 6 month period under section 41GA(1)(a)(i) of the Act

Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register.

Further information:

Revocation of suspension effective 23 August 2018.

Under section 41GD, the grounds for suspending this kind of device from the ARTG under subsection 41GA(1)(a)(i) no longer applies.

2017

Suspension start date: 20 Dec 2017

Suspension end date: 19 Jun 2018

Amplitude Australia Pty Ltd

Product name/ARTG reference: Eclipse BCP Absorbable Interference Screw

ARTG number: 284239

Type of regulatory action: Suspension from ARTG for a six month period under paragraph 41GA(1)(b) of the Act

ARTG 284239 was suspended by the Secretary in accordance with paragraph 41GA(1)(b) of the Act. The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure.

Further information:

The suspension was revoked by the Secretary on 18 January 2018 as the grounds on which the kind of medical device was suspended from the Register no longer applied.

Suspension start date: 8 Nov 2017

Suspension end date: 8 Sep 2018

LivaNova Australia Pty Ltd

Product name/ARTG reference: 3T heater-cooler device

ARTG number: 194514

Type of regulatory action: Revocation of suspension from the ARTG under section 41GD of the Therapeutic Goods Act 1989 (the Act).

Pursuant to subsection 41GA(1)(b) of the Act, there are likely grounds for cancelling the ARTG entry, in accordance with paragraphs 41GN(1)(f) and 41GN(1)(b) of the Act.

Further information:

A decision to extend the suspension period for an additional 6 months was made in accordance with section 41GC of the Act.

A decision to revoke the suspension of the entry from the ARTG was made on 18 September 2018 as the conditions under section 41GD(1)(a) of the Act had been met; the grounds for cancelling the ARTG entry no longer apply.

Suspension start date: 3 Oct 2017

Suspension end date: 3 Apr 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Embolisation Device with tip

ARTG number: 281030

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information:

Suspension effective for 6 months

Suspension start date: 3 Oct 2017

Suspension end date: 3 Apr 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Emobolisation Device w/out tip

ARTG number: 281033

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information:

Suspension effective for 6 months

Suspension start date: 14 Sep 2017

Suspension end date: 5 Feb 2018

Covidien/Medtronic Australasia Pty Ltd

Product name/ARTG reference: Puritan Bennett 980 Series Ventilator

ARTG number: 221416

Type of regulatory action: Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious injury or illness if the kind of device continues to be included in the ARTG.

Further information:

The Minister has revoked the suspension and substituted another decision following a review of the Secretary's decision under section 60 of the Therapeutic Goods Act 1989. See further information above.

Suspension start date: 31 Aug 2017

Suspension end date:

Endotherapeutics Pty Ltd

Product name/ARTG reference: SerenoCem Granules BCG050

ARTG number: 152441

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b).

Further information:

Suspension effective for 6 months. The suspension is limited to the SerenoCem Granules BCG050 only.

Suspension start date: 9 Jun 2017

Suspension end date:

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference: QuickVue One-Step hCG urine test kit

ARTG number: 254033

Type of regulatory action: Suspended from the ARTG under s.41GA(1)(b)

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Suspension start date: 9 Jun 2017

Suspension end date:

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference: QuickVue One-Step hCG urine test kit

ARTG number: 199827

Type of regulatory action: Suspended from the ARTG under s.41GA(1)(b)

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Suspension start date: 2 Jun 2017

Suspension end date: 1 Jun 2018

Lovell Surgical Supplies International Pty Ltd

Product name/ARTG reference: Cardiopulmonary bypass system heating/cooling unit

ARTG number: 262576

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Under subsection 41GA(1)(b); it is likely there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Further information:

A decision to extend the suspension period for an additional 6 months effective 02/12/2017 was made in accordance with section 41GC of the Therapeutic Goods Act 1989.

Following the submission of adequate evidence, the suspension has been revoked in accordance with section 41GD of the Act on 31 May 2018.

Suspension start date: 16 May 2017

Suspension end date: 16 Nov 2017

Philips Electronics Australia Ltd

Product name/ARTG reference: IntelliVue MX40

ARTG number: 99204

Type of regulatory action: Suspension from ARTG for a 6 month period under paragraph 41GA(1)(a)(i) of the Act

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious illness or serious injury if the kind of device continues to be included in the ARTG.

Further information:

The suspension has been revoked in accordance with section 41 GD of the Act on 16 November 2017

Suspension start date: 21 Apr 2017

Suspension end date: 21 Apr 2018

Australian Blood Management Unit Trust

Product name/ARTG reference: Cardiopulmonary bypass system heating/cooling unit

ARTG number: 278698

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection GN(1)(b).

Further information:

A decision to extend the suspension period for an additional 6 months was made in accordance with section 41GC of the Therapeutic Goods Act 1989.

The suspension has been revoked in accordance with section 41 GD of the Act on 20 April 2018.

2015

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

Product name/ARTG reference: Device Technologies Australia Pty Ltd - Mammary Implant-Silicone Gel-Smooth Surface - Prosthesis, internal, mammary, gel filled

ARTG number: 148764

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information:

A website publication on medical devices manufactured by Silimed can be found at: Silimed medical devices (all - including breast implants).

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