Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00838-3
Product Name/Description	Armada 35 and Armada 35LL percutaneous transluminal angioplasty (PTA) catheter (balloon dilation catheter) All part numbers are affected All lot numbers up to and including 783705 ARTG Number: 191827
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/08/2012
Responsible Entity	Abbott Vascular Division of Abbott Australasia Pty Ltd
Reason/Issue	Abbott Vascular has discovered that some percutaneous transluminal angioplasty (PTA) catheters may exhibit difficulty inflating and/or deflating.
Recall Action	Recall
Recall Action Instructions	Immediately remove and quarantine all inventory of affected part numbers so that they will not be used. Abbott Vascular will replace affected units with similar product, pending availability
Contact Information	1800 550 939 - Abbott Customer Service Department