Cook Medical initiated a voluntary recall of 4,146,309 catheters with its Beacon Tip technology on April 15 because of an issue pertaining to the catheter's tip. The defect can cause the tip to fracture and/or separate from the catheter.

"It's not an unexpected issue for tips to separate but we started seeing changes in the catheter's performance," Pete Yonkman, president of Cook Medical and Cook Group, told HCB News. "The materials in the tip of the device were degrading and we don't fully understand why."

If the catheter tip is separated, that could lead to complications including device fragments being left in the patients’ vascular system, genitourinary system or other soft tissues. Fragments in the vascular system can cause a heart or lung embolism, or blood flow could be blocked to end organs.
None of the patients died or were sent home with the catheter tip inside them, but surgeons had to retrieve the broken tips with snare devices in 30 cases, Indianapolis Business Journal reported. The cases were isolated to a few hospitals, so Cook Medical speculates that it's unlikely that the catheters were shipped with material or assembly defects.

The recall includes the 16 catheters in Cook Medical’s portfolio with Beacon Tip Technology. The company included a list of the recalled catheters in its statement.

After a preliminary investigation, it was revealed that environmental conditions including storage temperature, humidity and the use of vaporized hydrogen peroxide to decontaminate health care facilities may have contributed to this. However, other factors may also have contributed, so the company is continuing to investigate.

"We are taking a proactive step and recalling all catheters that use Beacon Tip technology," said Yonkman. "We want to make sure that we are reducing risk for patients."

This is not the first time that the company has issued a recall on its products — three other recalls have been made since July 2015. In July, 2,239 lots of Beacon Tip Angiographic Catheters were recalled, which amounted to 95,167 devices globally.

In October, Cook Medical issued another recall for select sizes of Beacon Tip Angiographic Catheters, which was an expansion of the lot-specific recall that was issued in July. The company reported that those catheters have resulted in 42 medical device reports.

In January, Cook Medical initiated a global recall of select lots of its Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Tray, because the catheter tips were prone to fracture and/or separation.

In addition, the company is dealing with a bunch of product lawsuits that claim that its medical devices have caused harm, reports the Indianapolis Business Journal. Hundreds of lawsuits have been filed claiming that some of the blood-clot filters have broken apart.

The current recall only accounts for 2 percent of Cook Medical's portfolio of 16,000 devices. The company is working hard to bring the product back to market, but until that time it is increasing production of its non-Beacon tip catheters to help physicians treat their patients.

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