The U.S. FDA has identified the Dragonfly OpStar imaging catheter from Abbott as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Dragonfly OpStar optical coherence tomography (OCT) imaging system is designed to provide imaging of blood vessels that carry blood and oxygen to the heart (coronary arteries) in people who are candidates for catheter-based, minimally invasive, interventional procedures to address coronary artery disease.
However, Abbott is recalling certain lots of the Dragonfly OpStar imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person, according to the FDA. The recall include 4,800 devices in the U.S.
A loose marker band that has separated from the device may remain in the body after the catheter is removed, potentially leading to vascular injuries, including but not limited to embolism (blockage of the vessel), thrombosis (blood clot), dissection (tear), ischemia (inadequate blood supply to the heart), infarction (heart attack), infection, or death.
There have been five incidents and one injury related to this device issue. No deaths have been associated with the use of this device due to this issue.
Abbott issued an Urgent Medical Device Recall letter to all customers who received affected devices. The following instructions were included:
- Immediately stop using devices from affected lots
- Review inventory and complete the Effectiveness Check Form Included with the Urgent Medical Device recall letter.
- Return all unused affected devices to Abbott.
- Share this information with all relevant personnel.
- Notify anyone who may have received these affected products through additional distribution or transfer.
- Report any product performance issues or adverse events to Abbott.