Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter.
The manufacturer is initiating a recall removal of one lot of the Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter [Catalog No.: 39186-25121; Lot 16397693] and one lot of the Coyote MONORAIL PTA Balloon Dilatation Catheter [Catalog No.: 39185-20151; Lot 16310947]. The manufacturer has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, the manufacturer has received three complaints for this issue.
According to the manufacturer, the most common adverse health consequences resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention.
The manufacturer instructs all affected users to cease immediately further distribution or use of any remaining product affected by this medical device safety alert.
According to the local supplier, the affected products were NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 06 February 2014