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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