Cook Medical, the Bloomington maker of medical devices, is recalling 4.1 million catheters after receiving dozens of reports of tips splitting or breaking, requiring surgeons to retrieve them from inside the patient.
No patients have died as a result of the faulty products, and no patients were sent home with a tip still inside them, the company said Monday. But in about 30 cases, surgeons had to retrieve the broken tips with a snare device during the same procedure.
It’s the largest recall in recent years for Cook, which previously had issued four recalls covering more than 400,000 catheters and pressure-monitoring sets in the past two years.
Cook said it was still trying to determine what happened to cause the catheters to fail. It pointed out that the complaints were isolated to a few hospitals, where professionals discovered that the tips, made of tungsten and nylon, using “Beacon Tip” technology, were degrading.
Cook employees were sent to the hospitals to investigate, company president Pete Yonkman said in an interview Monday. They discovered that those hospitals were using new sterilization technologies involving vaporized hydrogen peroxide to clean operating rooms if patients were infected with “superbugs”–or extremely resistant bacteria, such as methicillin-resistant staphylococcus, known as MRSA.
The hospitals had left Cook’s catheters in the operating room during the sterilization process, he said.
“We’ll try to do a root cause analysis, try to figure out exactly what’s going on in the environment, what these whole-room sterilization technologies are, and understand how they are impacting our devices,” Yonkman said.
Because the reports were so isolated, it appeared unlikely the catheters were shipped with material or assembly defects, he said.
The catheters are used for vascular procedures outside the heart, including minimally-invasive urology or reproductive surgical procedures, he said.
Cook makes about 1.5 million of the Beacon Tip catheter tips a year, representing about 2 percent of Cook Medical’s product portfolio.
The recall comes as Cook is also dealing with a deluge of product lawsuits claiming the company’s medical devices harmed them. Patients from around the country have filed hundreds of lawsuits, alleging that some of the blood-clot filters have broken apart, sometimes requiring medical procedures to remove them. The suits were consolidated last year in federal court in Indianapolis.
Last summer, Cook recalled about 96,000 Beacon Tip catheters and expanded that to 408,000 in October. In 2014, Cook recalled 696 vascular retrieval snare devices, which required medical intervention in four cases.
The company said it might change the labeling or packaging but planned to retain the Beacon Tip name.
“The technology is a very good technology,” Yonkman said. “We just need to understand more how it’s behaving in the environment.”