Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

Abbott has recalled its Dragonfly OpStar imaging catheter, used for imaging the coronary arteries with optical coherence tomography, due to the possibility that the marker band farthest from the tip of the catheter could become loose and harm the patient, the US Food and Drug Administration announced Thursday. The recall has been deemed Class I, the most serious type.

The issue has been associated with five incidents and one injury, but no deaths. In two cases, the loose band separated completely from the catheter while it was in use. If that happens and the band remains behind in the patient, it could cause vascular injury or death, according to the FDA note.

The recall, which Abbott initiated on April 11, applies to 4,800 devices distributed in the United States. Affected catheters, with lot numbers listed in the FDA’s recall database, should be returned to the company.