Cook Medical has initiated a global, voluntary recall of all catheters with its Beacon Tip technology
The catheters were recalled on April 15, 2016 due to complaints of tip splitting and/or fracture.
Catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip.
According to Cook Medical, potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment.
Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolisation to the heart or lungs, or occluding blood flow to end organs.
However, Cook highlighted that most of the fractures and/or separations were discovered prior to patient contact.
The US Food and Drug Administration (FDA) has not yet classified the recall, but the company has notified the FDA and other regulatory agencies around the world of this action.
In 2015, Cook recalled specific lot numbers of Beacon Tip catheters and then expanded that recall to all four French lots. Due to an increase in complaints about tip splitting and/or fracture, in April 2016 Cook has now recalled all lots and sizes.
Pete Yonkman, president of Cook Medical and Cook Group, said: “We’ve been investigating a variety of factors including environmental influences and it’s been difficult for us to reproduce the exact failures that our customers have experienced.
“If we cannot tell our customers how to keep our products safe, then we aren’t comfortable leaving them on the market. It’s a risk we’re not willing to take. Patient safety comes first – period.”