Just a few weeks after Abbott began asking healthcare providers who had purchased certain lots of its imaging catheters to immediately return any unused devices, the FDA has upgraded the recall with its most serious classification.
The recall covers more than 14,500 Dragonfly OpStar imaging catheters that had been distributed around the world, according to the agency’s database entry, including 4,800 that were sold in the U.S. alone.
The single-use devices and an accompanying software system use optical coherence tomography technology to generate images of the coronary arteries. Abbott received FDA clearance for the catheter in 2019 for use in people who are candidates for catheterization procedures in coronary artery disease.
The company initiated the recall on April 11, and this week, the regulator handed down a Class I rating, meaning the affected devices carry a heightened risk of serious injury or death.
The recall stems from an issue with a marker band on the catheter. Marker bands are small rings that are placed at predetermined points along a catheter and made of radiopaque materials that make them visible through an X-ray feed, helping to guide the movement and placement of the device.
The marker band placed farthest from the catheter tip in some lots of Dragonfly OpStar devices has been found to be at risk of coming loose while the catheter is in use, per the FDA’s safety notice. In at least two cases, the marker band has completely separated from the catheter while it was inside a patient’s blood vessel.
If that happens and the marker band is left inside the artery, it could cause a blockage, clot or tear in the vessel, potentially leading to a blockage of the blood supply to the heart, a heart attack, an infection or even death, the FDA said.
So far, Abbott and the agency have received reports of five incidents and one injury linked to the issue but no deaths.
Healthcare providers who purchased catheters from the affected lots are being asked to immediately stop using them and return all unused devices to Abbott. Though the recall doesn’t affect those catheters that have already been used, providers and patients should continue to report any adverse events that may have stemmed from the devices to the company and the FDA.
Unlike many of its fellow medtech giants, Abbott has largely avoided racking up Class I recall labels from the FDA, garnering only one in each of the last two years and none in 2019.
The most recent of these arrived last October, when the agency slapped its most serious rating on a recall of the software used to prepare swab samples for testing with some of Abbott’s PCR tests for COVID-19. In some cases, the software was found to program too much liquid to be added to a sample, causing it to overflow and potentially contaminate nearby samples in the processing tray—potentially leading to false-positive results for the contaminated samples.