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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