Type of Product |
Medical Device |
TGA Recall Reference |
RC-2013-RN-01260-1 |
Product Name/Description |
HT Connect Peripheral Guide Wires (used for percutaneous transluminal Agioplasty (PTA) in peripheral arteries)
Part Numbers: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594 and 1012595
ARTG Number: 191394 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
27/11/2013 |
Responsible Entity |
|
Reason/Issue |
Abbott Vascular has initiated a recall action for HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating. The potential risks associated with delimination of the coating include embolism, thrombus and occlusion in the peripheral vessels. |
Recall Action |
Recall |
Recall Action Instructions |
Abbott Vascular is requesting users to immediately remove and quarantine all affected part numbers and return to Abbott Vascular. Abbott Vascular is replacing returned units with similar product, pending availability. Abbott Vascular has ceased distribution of the product while investigating and correcting the issue. |
Contact Information |
1800 550 939 - Abbott Vascular Customer Service |