Abbott imaging catheter recall flagged as Class I by FDA

The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall.

That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11.

The recall affects 4,800 devices in the U.S. from certain lots. Abbott is asking health care providers to stop using the devices.