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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00422-1
Product Name/Description Edwards Lifesciences Fem-Flex II Cannulae

Model Numbers: FEMII016A, FEMII018A & FEMII020A

All Lot Numbers

ARTG Number: 177959
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 9/04/2014
Responsible Entity Edwards Lifesciences Pty Ltd
Reason/Issue Edwards Lifesciences has received five complaints globally in the last four months involving the separation of dilator tips on specific models of Fem-Flex II arterial cannula sizes 16, 18 and 20 French. Some of the reported events involved separation of the tip of the dilator and required retrieval through an interventional radiologic procedure.
Recall Action Recall
Recall Action Instructions Edwards is requesting hospitals to quarantine and return the affected devices immediately.
Contact Information 1800 222 601 - Edwards Lifesciences Customer Service