Medical device manufacturer, Medtronic International Ltd., is notifying customers that they are in the process of updating the Instructions for Use of DLPR Single Stage Venous Cannulae.
Medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use. The following statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use:
"DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES."
According to the local supplier, the affected products have been distributed in Hong Kong. If you are in possession of the affected product, please contact your supplier for more information.