You are here

Medical devices and IVDs: Suspensions from the ARTG

16 September 2021

Medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods following a review by the TGA. 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.

Changes to the visibility of suspended medical devices

From 16 September 2021, the visibility of suspended medical devices in the ARTG database has changed, with the suspended medical devices no longer visible in the ARTG database on the TGA web site . The suspended medical device is not visible as it cannot be lawfully supplied. In addition, the ARTG certificate and record summary of the suspended medical device will be watermarked as 'Suspended'. Sponsors of a suspended medical device will not be able to submit an application to vary their medical device entry or transfer the ARTG entry to another sponsor whilst the medical device remains suspended.

Medical devices and IVD suspensions

Displaying 1 - 25 of 67

2021

Suspension start date: 28 Jul 2021

Suspension end date: 29 Dec 2021

Nuvasive (Aust/NZ) Pty Ltd

Product name/ARTG reference: Spinal distraction rod

ARTG number: 231043

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

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

2020

Suspension start date: 24 Nov 2020

Suspension end date: 24 May 2021

Australasian Medical & Scientific Ltd

Product name/ARTG reference: t:slim X2 insulin pump/Infusion pump, insulin, ambulatory

ARTG number: 304681

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

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

Revocation of suspension effective 1 April 2021.

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) & (1)(e) no longer apply.

Further information about this device is available in a related safety alert.

Suspension start date: 11 Nov 2020

Suspension end date: 11 May 2021

Karl Storz Endoscopy Australia Pty Ltd

Product name/ARTG reference: Hysteromat E.A.S.I / (Hysteroscopic irrigation/distention system)

ARTG number: 148024

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

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

2019

Suspension start date: 25 Oct 2019

Suspension end date: 24 Apr 2020

Allied Scientific Products Pty Ltd

Product name/ARTG reference: GFX gel-filled Nagor mammary implant range - textured - Prosthesis, internal, mammary, gel filled

ARTG number: 142863

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

Allied Scientific Products Pty Ltd

Product name/ARTG reference: 9-cell CoGel gel-filled Nagor mammary implant range - textured - Prosthesis, internal, mammary, gel filled

ARTG number: 277757

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 25 Apr 2020

Allied Scientific Products Pty Ltd

Product name/ARTG reference: Impleo gel-filled Nagor mammary implant range - textured - Prosthesis, internal, mammary, gel filled

ARTG number: 277758

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

Euro Implants Pty Ltd

Product name/ARTG reference: Round Cristalline Paragel Mammary Implants, Soft Cohesive Silicone Gel, textured - Prosthesis, internal, mammary, gel filled

ARTG number: 132037

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

Euro Implants Pty Ltd

Product name/ARTG reference: Cristaline I Aptex/Vertex Paragel Natural Cohesive Gel Implant (The Matrix Anatomic Cristalline Paragel Mammary Implants Natural Cohesive Gel, textured - Prosthesis, internal, mammary, gel filled)

ARTG number: 132040

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

JT Medical Pty Ltd

Product name/ARTG reference: Sublime Line, Microthane, Silicone gel filled Mammary Implants - Prosthesis, internal, mammary, gel filled

ARTG number: 171782

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

JT Medical Pty Ltd

Product name/ARTG reference: 4Two Line, Single Lumen, Micro Polyurethane, Silicone gel filled Mammary Implants - Prosthesis, internal, mammary, gel filled

ARTG number: 185060

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

Under subsection 41GA(1)(b); it 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: 25 Oct 2019

Suspension end date: 24 Apr 2020

Emagin Pty Ltd

Product name/ARTG reference: Anatomical Breast Implants - Textured - High Cohesive Gel - Prosthesis, internal, mammary, gel filled

ARTG number: 309613

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

Under subsection 41GA(1)(b); it 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: 18 Oct 2019

Suspension end date: 20 Apr 2020

Point Of Care Diagnostics Australia Pty Ltd

Product name/ARTG reference: LeadCare II Blood Lead Analyzer

ARTG number: 255472

Type of regulatory action: Extension of Suspension from the ARTG under paragraph 41GC of the Act

Under subsection 41GA(1)(b); it 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: 11 Sep 2019

Suspension end date: 11 Mar 2020

Erskine Products Pty Ltd

Product name/ARTG reference: Dechoker LLC - Suction Unit, <specify> [36776]

ARTG number: 301006

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

Under subsection 41GA(1)(b); it 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

2018

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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: Revocation of suspension

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.

Further information:

The suspension was revoked by the Secretary as the grounds for cancelling this kind of device from the ARTG no longer apply.

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.

Further information: ARTG 135587 was cancelled from the Register by the sponsor on 29 March 2019.

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 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.

Pages