Cook Medical Issues Global Voluntary Recall for All Beacon Tip Catheters
May 2, 2016—Cook Medical has initiated a global voluntary recall of all catheters made with its Beacon Tip technology, representing approximately 4.1 million units.
The Beacon Tip technology, which was developed in the late 1990s, has a radiopaque, tungsten-loaded tip. In 2015, Cook recalled specific lots of its Beacon Tip catheters, totaling 96,661 at the time, and later expanded that recall to all 4-F lots (408,000 catheters). Due to an increase in complaints of tip splitting and/or fracture, Cook expanded the recall on April 15, 2016, to all lots and sizes of the Beacon Tip catheter in an effort to ensure patient safety while the company works to determine the root cause of the issue and correct it. A list of affected lines is available on Cook's website.
According to the company, the affected catheters have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Most of the incidences were discovered before patient contact. The US Food and Drug Administration (FDA) and other global regulatory agencies have been notified of this action, as have customers. The FDA has not yet classified the recall.
“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,” said Pete Yonkman, President of Cook Medical and Cook Group, in the company’s press release regarding the recall. “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.”
Although catheter tip separation can occur for various reasons and is not an overall new phenomenon, Cook has not previously seen this type of material change. As such, the company is evaluating the unique aspects of the polymer degradation recently observed in Beacon Tip devices to pinpoint the source and better understand why it is occurring.
“What we saw was an unexpected failure, a material degradation,” said Mr. Yonkman in comments to Endovascular Today. Initially, the degradation was only observed in the 4-F line, prompting the first recalls. Then, earlier this year, Cook began to see the same failure mode occur in other sizes. Due to the increasing frequency of the observance and the inability to determine its cause, the decision was made to recall all Beacon Tip devices.
Mr. Yonkman described some of the efforts Cook is making to determine the root cause of the degradation. Device failures, he said, tend to occur across all types of hospitals and regardless of location. In this case, however, the degradations were observed and reported in clusters.
To investigate the problem, Cook sent teams into hospitals reporting the device issues. One reported element being further evaluated is a possible link between the material degradation and whole-room sterilization processes, which can take place while devices are present in the room.
“Hospitals are concerned, rightly so, about MRSA and superbugs, so they are bringing in new technologies to sterilize whole operating rooms,” said Mr. Yonkman. This process can involve exposure to high-intensity ultraviolet lighting, high-temperature–producing devices, or vaporized hydrogen peroxide, which Mr. Yonkman says may affect device materials, particularly devices that have nylon and tungsten in them. “We want to make sure that when a device is used by a customer, it behaves exactly the way it behaved when it left our door, no matter what environment it’s in,” he continued. Cook will work to return the product to market once the root cause is clearly identified and a solution is in place. This could include design and/or labeling modifications.
In the meantime, Cook will increase production of catheters that do not include the tungsten-loaded tip. Mr. Yonkman says the company anticipates being able to supply about half of its market with these devices within 6 weeks. The company is not currently concerned this line will experience material degradation in the same environments because the effect has not been observed in its other product lines to date.
Cook has also already notified other catheter manufacturers of the issue, a step Mr. Yonkman indicated the company undertook for several reasons. First, Beacon Tip catheters are widely used, with about 1.5 million units made each year. With some time between the recall going into effect and more widespread availability of non-Beacon Tip Cook catheters, the company is giving manufacturers with competing lines time to prepare for possible increased demand so that physicians and patients can continue to have access to necessary catheters during the recall. In addition, Cook wanted to inform other manufacturers of potential issues related to tungsten and nylon that may not be specific to Cook products.