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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00578-1
Product Name/Description	Wingman35 Crossing Catheters Wingman 35 Crossing Catheter, 65cm Reference: WGM35065CE Lot Numbers: 15087074R1 Wingman 35 Crossing Catheter, 90cm Reference: WGM35090CE Lot Numbers:1505144R, 1508264, 1603214R2, 1605194R Wingman 35 Crossing Catheter, 135cm Reference: WGM35135CE Lot Numbers: 1505264, 1508204, 1604213R, 160620R ARTG Number: 246377
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	9/05/2017
Responsible Entity	Diverse Devices Pty Ltd
Reason/Issue	The manufacturer ReFlow Medical, has identified specific lots of Wingman35 Crossing Catheters may be prone to tip detachment. If a catheter tip detaches from the Wingman 35 Crossing Catheter within the vasculature, it could cause injuries to blood vessel walls, thrombotic events, foreign body embolisation, heart attacks and death. The manufacturer has received no reports of injury or death associated with the tip failures.
Recall Action	Recall
Recall Action Instructions	Diverse Devices is advising users to stop using and quarantine all affected products. Affected products are to be returned to Diverse Devices for replacement. This action has been closed out on 02/11/2018
Contact Information	02 9976 2710 - Diverse Devices