Cook Medical said today that it is re-launching its Beacon Tip Torcon NB advantage catheters in the US and Canada, after having recalled the devices due to complaints related to device tips on the items degrading and fracturing.
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 1st noticed the problem in early 2015, initially recalling only the smallest size Beacon Tip angiography catheter.
Cook Medical said its engineering team completed significant testing after the recall, and that the devices are now shipped with a new foil outer packaging to provide a barrier against environmental factors it 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. We knew the product was in high demand, and how heavily physicians relied on this product. But, patient safety comes first, period,” Cook Medical vascular division VP Mark Breedlove said in a press release.
Last month, Cook Medical said it won the second of three bellwether cases brought against it alleging that its inferior vena cava filters designed to capture and contain blood clots were defective.