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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00294-1
Product Name/Description	Edwards Fem-Flex II Femoral Arterial Cannula, sizes 8, 10 & 12 French Product Codes: FEMII008A, FEMII008AT, FEMII010A, FEMII010AT, FEMII012A & FEMII012AT ARTG Number: 177959 Product Codes: FEMII008V, FEMII010V & FEMII012V ARTG Number: 142782 Multiple lot numbers affected ARTG number: 142782
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	31/03/2015
Responsible Entity	Edwards Lifesciences Pty Ltd
Reason/Issue	Through post market surveillance, Edwards Lifesciences has identified a potential health risk to patients regarding the use of Fem-Flex II Femoral Arterial Cannula, sizes 8, 10, and 12 French only. Edwards has received one customer complaint regarding a released wire, located at the tip area of the cannula, which was identified prior to use. Although the condition does not affect the functionality of the cannula, there is potential patient safety risk if a protruding wire is not detected prior to use. In a worst-case scenario, if the physician attempted to insert the device, the exposed wire could damage the femoral artery, causing a vascular injury that could require surgical or interventional repair. While there have been no reports of injury associated with this issue, Edwards is taking this action to eliminate the chance of tissue damage caused by a protruding wire.
Recall Action	Recall
Recall Action Instructions	All affected product is being Recalled from the Market. This action has been closed-out on 17/08/2016.
Contact Information	1800 222 601 - Edwards Customer Service