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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00810-1
Product Name/Description	Anastaflo Intravascular Shunt ( Carotid artery shunt) Model numbers: IVS1512 & IVS2012 All lot numbers ARTG Number: 155725
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	1/08/2013
Responsible Entity	Edwards Lifesciences Pty Ltd
Reason/Issue	Through post market surveillance data review, Edwards Lifesciences has identified a potential health risk to patients undergoing by-pass surgery when an Anastaflo Intravascular Shunt is used. Edwards has received twenty-three complaints concerning excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts. There have been no reports of injuries in any of these complaints. No events have been reported in Australia.
Recall Action	Recall
Recall Action Instructions	Customers are asked to quarantine affected stock and return all devices with remaining shelf life to Edwards Lifesciences. Customers can contact Edwards Lifesciences to obtain replacement product.
Contact Information	1800 222 601 - Edwards Lifesciences