FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter

Editor's Note

The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious.

The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control of hemorrhage is required.

The recall was issued because of the possibility of a blocked guidewire lumen in some device units. If a device with a blocked guidewire lumen were used, hemorrhage could not be controlled, which could result in adverse consequences, including death.

Manufacturing dates are February 13, 2017, to July 18, 2017, and distribution dates are February 24, 2017, to July 31, 2017.