Cook Medical issued an urgent field safety notice in Europe to warn of an issue with its Beacon Tip 5.0 Fr angiographic catheter.
The company identified an issue in which affected device lots may experience tip separation. This prompted Cook to request that customers remove devices from use, quarantining them and returning them to the company.
Beacon Tip catheters, which come in various configurations, facilitate diagnostic and therapeutic procedures. Configurations include different shaft lengths and tip curves, while some feature a hydrophilic coating. Trained physicians use the catheters in angiographic procedures.
Four field complaints led to Cook Medical identifying that users reported tip separation occurring both prior to and during patient contact. Further investigation revealed the issue to be the result of a process deviation by one specific operator.
Potential adverse events that may occur if physicians use the affected catheter include harms associated with device fragmentation/separation and vessel injury. To date, Cook Medical reports three customer complaints related to the adverse patient effects for the affected lots.
This isn’t the first time the company has recalled a product from its Beacon line of catheters due to a similar issue. The Bloomington, Indiana-based company recalled all catheters that used its Beacon Tip locating technology in May 2016. Like this time, it reported complaints of tip splitting, affecting a total of approximately four million devices. The company first noticed the problem in early 2015, initially recalling only the smallest size Beacon Tip angiography catheter.
Cook Medical relaunched the Beacon Tip catheters in Europe in September 2019, three years after its global market withdrawal.
