Cook Medical has announced that physicians in the US and Canada are once again able to order the company’s Beacon Tip Torcon NB Advantage 5F catheter, used in angiographic procedures. In 2015 and 2016, Cook recalled all Beacon Tip catheters due to an unexpected increase in complaints.
The relaunch comes after significant testing by engineering following the global recall. A change customers will notice is a new foil outer packaging that provides a barrier against environmental factors that were identified as contributing to the recall.
“When we saw the catheters acting in unexpected ways without a clear root cause, we knew we had to recall,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We knew the product was in high demand, and how heavily physicians relied on this product. But, patient safety comes first, period.”
After the recall, the company says they received a high volume of physician responses demanding the product. Cook Medical also explains it devoted many operational, manufacturing and engineering resources to determine the most efficient path back to market.