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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