Cook Medical said today that has relaunched its Beacon Tip catheters in Europe, three years after withdrawing them from the market worldwide.
The catheters are now available in the UK, Ireland, Norway, Sweden, Finland, Denmark, Germany, Poland, the Netherlands, Luxembourg, Belgium, France, Switzerland, Austria, Hungary, Spain and Italy. Cook said it is working on relaunching the catheters in the rest of Europe, the Middle East and Africa “in the near future.”
The Bloomington, Ind.-based company recalled all catheters that used its Beacon Tip locating technology in May 2016 over 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.
The catheters are used for diagnostic angiographic procedures and have a visible distal tip designed to improve visualization when using fluoroscopic guidance. Cook relaunched them in the US and Canada in 2018. The company said today that it has changed the product packaging to protect the catheters from the type of damage that prompted the recall and that they meet the regulatory standards of multiple governing bodies.
“Patient safety is always a priority for us, and we are proud of the changes we have made,” said Mike Williams, global director of Cook Medical’s vascular programs in a news release. “Improved packaging allows for physicians to once again have access to catheters, designed for torqueability, visibility and pushability, to improve procedural outcomes.”
In 2016, Cook Medical issued a voluntary global recall of all Beacon Tip Catheters following concerns that the tips were fracturing due to environmental factors. As patient safety is always a priority, engineers at Cook began intensive testing to find a solution. The products now come with specialized foil packaging to help protect the catheters from the environmental effects that contributed to the recall.