HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves) 의 리콜

Recall

RC-2017-RN-00232-1

Class II

2017-02-14

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00232-1

The manufacturer, lemaitre vascular is extending the scope of the recall of hydro lemaitre valvulotome devices undertaken in august 2016 (tga ref.: rc-2016-rn-01046-1). 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 and has led to vessel damage. if the blades are stuck in the open position, the device must be removed in the open state. the removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel.

Emergo is advising customers to immediately quarantine and return unused devices from the affected lots. Returned devices will be replaced with unaffected devices.