Recall of Absorb Bioresorbable Vascular Scaffold (BVS) System

ACT Health is alerting the community to the hazard alert and recall for Absorb Bioresorbable Vascular Scaffold (BVS) System that has been issued by Abbott Vascular Australia, in consultation with the Therapeutic Goods Administration (TGA).

Absorb BVS System is an implanted medical device (stent) that opens blocked coronary arteries and is fully absorbed by the body overtime.

The device is also being removed from the Australian Register of Therapeutic Goods (ARTG).

The decision to undertake this recall is in response to data from some recent studies showing an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with another alternate stent.

ACT Health is advising people who have received an Absorb BVS System and are concerned to talk to their health professional to ensure that they are receiving appropriate treatment and know the signs and symptoms of heart attack and blood clot.

If people are experiencing any new cardiac-related symptoms, such as irregular heartbeats, chest pain, or shortness of breath, seek immediate medical attention.

In the coming days, ACT Health will be providing any effected patients further information and advising them to speak with their health professional.

Abbott Vascular Australia has written to health professionals who have implanted Absorb BVS System to provide them further information about this issue, including details of the recall procedure.

Consumers and Health Professionals with concerns about this issue are also advised they can contact Abbott Vascular Australia on 1800 550 939.

Further information about the recall is available on the Therapeutic Goods Administration website at: www.tga.gov.au/alert/absorb-bioresorbable-vascular-scaffold-system