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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01048-1
Product Name/Description	Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter Model Numbers: AMD253210002, AMD025150152, AMD030120152 Lot Numbers: 209425769, 209436620, 209470464, 209470474, 209507756, 209553426, 209664051, 209722663, 209760068 ARTG Number: 154327
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/10/2015
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	The potential for a sterile breach in the pouch material was discovered during standard internal packaging tests. The pouch seal breach could potentially result in compromised sterility of the product. Following the instructions for use (IFU) would reduce the risk of potential patient harm if issue was easily detectable but in most cases it is not. There have been no reports of adverse patient events related to this issue.
Recall Action	Recall
Recall Action Instructions	Customers are advised to remove and quarantine and return all units of the Amphirion Deep Balloon Catheter that remain in their inventory. Patients who have received treatment with an Amphirion Deep PTA Balloon Dilation Catheter affected by this recall should continue to be monitored in accordance with the standard practice. This action has been closed-out on 22/08/2016.
Contact Information	1800 668 670 Medtronic