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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01046-1
Product Name/Description	1.5 mm HYDRO LeMaitre Valvulotome, 40 cm (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves) Reference number: 1010-00 Lot numbers: ELVH1089V, ELVH1091V Expiry date : 2021-03 Lot numbers: ELVH1099V Expiry date : 2021-05 ARTG number: 218706
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/08/2016
Responsible Entity	Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Reason/Issue	The centering hoops keep the head of the HYDRO LeMaitre Valvulotome centered in the vessel and prevents the valve-cutting blades from damaging the vessel wall. There have been reported issues of hoops failing to close when the device was actuated. In some cases, this issue has been discovered in-use. While no adverse events have been reported, there is the possibility that a malfunctioning device could damage the vessel upon withdrawal.
Recall Action	Recall
Recall Action Instructions	Emergo is advising users to locate, quarantine and return all affected product. Returned devices will be replaced with unaffected devices. This action has been closed-out on 02/03/2017.
Contact Information	02 9006 1662 - Emergo Australia