FDA: Class I recall of Abbott’s Dragonfly OpStar Imaging Catheter

Editor's Note

The Food and Drug Administration (FDA) on May 26 identified the recall of Abbott Medical’s Dragonfly OpStar Imaging Catheter as Class I, the most serious.

Abbott is recalling certain lots of the imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose and separate from the catheter while being used in a patient.

The device is designed to provide imaging of blood vessels that carry blood and oxygen to the heart in patients who are candidates for catheter-based, minimally invasive, interventional procedures for coronary artery disease.

To date, there have been five incidents, one injury, and no deaths reported.