FDA Provides Update on Abbott’s Recall of Dragonfly OpStar Imaging Catheter

The FDA has deemed Abbott’s April 11 recall of certain lots of its Dragonfly OpStar imaging catheter a Class 1 recall because of the risk of serious injury or death.

The OpStar catheter uses tomography to image the coronary arteries in people who are candidates for catheter-based, minimally invasive interventional procedures for coronary artery disease.

The reason for the recall is the risk of the marker band farthest from the catheter tip becoming loose. In two instances, the marker has separated from the catheter while being used on a person, the agency said.