UPDATED May 5, 2016, with comment from Cook Group president Pete Yonkman.
The catheter recall that’s been bedeviling Cook Medical since last year grew last month as the company recalled all lots of catheters using its Beacon Tip locating technology, but the company expects to have replacement catheters on the market within the next several weeks.
The move stems from an increase in reports that the polymer used in the tips degrades over time, causing the tips to fracture or separate during procedures. Cook Medical said it’s received 30 reports of tip splitting to date, prompting the recall of some 4 million of the devices.
Cook Group president Pete Yonkman told MassDevice.com that the company 1st noticed the problem last year and initially recalled the smallest size Beacon Tip angiography catheter.
“Last year, we recalled our 4 French Beacon Tips, our smaller size of Beacon Tip catheters, because we were seeing this unexpected failure. It was a material degradation – you were seeing the material go from a pliable plastic to a harder material. The material was actually changing. We weren’t sure at the time what that was, but because we saw it in a sufficient rate, we recalled all the 4 French catheters,” Yonkman told us.
Further investigation by the company revealed what he called “clusters” of similar incidents in hospitals using whole-room sterilization procedures for their operating rooms, aiming to lower the rate of hospital-acquired, drug-resistant infections.
“As we were doing an investigation, what was interesting was, we weren’t seeing it across the globe evenly. We were sort of seeing it in clusters. There would be lots of products that were having the same type of failure at a specific hospital,” Yonkman explained. “We were starting to see that these customers were using technologies that were trying to sterilize their ORs. They were using technologies like UV, high-intensity UV. Some were using vaporized hydrogen peroxide, [at] high temperature.
“What they’re trying to do, rightly so, is get rid of these superbugs or MRSA, that sort of thing. We were seeing a correlation because they were leaving our products in the room as they were doing this,” he said. “Our testing shows that that material or those types of sterilization procedures can degrade materials, particularly when you have nylon and tungsten, which is what these types of catheters use.”
The decision to recall more devices was made after the root cause for the polymer degradation eluded Cook’s investigators, Yonkman noted.
“We wanted to make sure we had time and we were reducing risks to patients while we were doing that root cause investigation,” he said, adding that Cook notified its competitors of the recall out of concern for patients’ wellbeing.
“We reached out and talked to our competitors in this space because, as we were recalling it, we wanted them to have the opportunity to increase their capacity. We’re already ramping up our non-Beacon Tip options. We didn’t want there to be any gaps in the market, because we know how important these technologies are for our customers,” Yonkman told us.
At least 1 of Cook Medical’s rivals is looking to capitalize on the recall. Merit Medical (NSDQ:MMSI) chief Fred Lampropoulos said last week that his company is ready to take advantage.
“In the 35 years I have been in the industry, I have never seen anything like this. It’s so unfortunate for a great company,” Lampropoulos saud during a conference call with analysts discussing Merit’s 1st-quarter results. “It’s going to be, I think, a long time. Once you start pulling product you have to get it, of course, re-qualified. I do not want to speak on behalf of Cook, nor would be appropriate, but it’s going to be long and it’s going to be deep and it’s going to create a great opportunity for Merit.”
Yonkman said he expects to have replaced the recalled Beacon Tip devices with other catheters in 3 to 6 weeks.
“We are already ramping up and producing non-Beacon Tip catheter options. I think we’ve already replaced 30% of that product line in terms of sales. Within the next few weeks, we hope to have over 60% or 70% of those products replaced with non-Beacon Tip catheters,” he said.
Cook’s full list of recalled Beacon Tip catheters can be found here.
