| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00517-1 |
| Product Name/Description |
Absorb Bioresorbable Vascular Scaffold (BVS) System
ARTG Number: 214148 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Vascular advises that, effective immediately, the Absorb Bioresorbable Vascular Scaffold (BVS) System will only be available for use in clinical registry and Special Access settings. Data from recent analyses have demonstrated that optimal implantation technique is critical to achieving good clinical outcomes. Limiting use of this device to select hospitals/institutions will enable Abbott to collect additional data and monitor implantation techniques.
In light of recent concerns over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis, Abbott Vascular awaits further data to confirm whether improved implantation techniques will mitigate these higher event rates. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott Vascular has removed the product from the ARTG and is recalling all stock from the market until further notice. For further information please see https://www.tga.gov.au/alert/absorb-bioresorbable-vascular-scaffold-system
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 550 939 - Abbott Vascular Customer Service |