Abbott is recalling certain lots of its imaging catheter with OCT because the marker band farthest from the catheter tip may become loose and separate from the catheter during use.
According to an FDA press release, a proximal marker that has separated from the device (Dragonfly OpStar) may remain in the body after catheter removal, and may cause embolism, thrombosis, dissection, ischemia, MI, infection or death.
The catheter is designed to image the coronary arteries of patients who are candidates for catheter-based, minimally invasive, interventional procedures to treat CAD.
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