The FDA has designated Cook Medical’s recall of its Beacon Tip 5.0 Fr angiographic catheter as Class I, the most serious level.
Users reported tip separation occurring both before and during patient contact, according to an FDA notice published today. As a result, catheter fragmentation and embolization might occur with the catheters involved in the recall.
Cook sent letters to affected customers on May 15, and MassDevice reported an urgent field safety notice in Europe on May 16.
Cook has reported three serious injuries and no deaths associated with the issue, according to the FDA.
Trained physicians use Beacon Tip catheters in angiographic (blood vessel imaging) procedures. Cook Medical offers the catheters in various configurations, including different shaft lengths and tip curves. Some feature a hydrophilic coating.
This isn’t the first time the company has recalled a product from its Beacon line of catheters due to a similar issue. In May 2016, the Bloomington, Indiana–based company recalled all catheters that used its Beacon Tip locating technology. Like this time, it reported complaints of tip splitting, affecting roughly 4 million devices.
