The Cook Medical recalling 4 million catheters with Beacon Tip technology greatly expands an initial recall from last year.
Cook Medical announced this week that it is voluntarily recalling all of its catheters with Beacon Tip technology—about 4.1 million units globally—because of complaints of the tips splitting or fracturing during procedures.
The Bloomington, IN–based medical device company initiated the recall on April 15. The recall further expands on a much smaller 2015 recall that involved 95,167 devices. Cook officials have now decided to recall all lots and sizes to “assure patient safety.”
The nylon catheter tips appear to be susceptible to polymer degradation, with 30 reports of problems received so far. In some cases, a secondary procedure was needed to retrieve a fractured tip from a patient, said Cook spokeswoman Marsha Lovejoy. There have been no deaths associated with the. recall.
The preliminary investigation into the problem suggests that storage room environment—including temperature, humidity, and the use of vaporized hydrogen peroxide for whole-room decontamination—may be playing a roll. Company officials, though, recognize that there may be other undetermined contributors to the problem.
“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,” Pete Yonkman, president of Cook Medical and Cook Group, said in a news release. “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.”
Added Lovejoy: “We want to take a leadership role in investigating how environmental issues like whole room sterilization can play a role in how a device functions. If environmental factors are playing a role in material degradation, we want to understand why the material is changing and provide a solution. Our products should perform in the OR the same way they perform when they leave a Cook facility.”
Cook customers and distributors have been notified via letter, and have been asked to stop using the Beacon Tip catheters and to return them as soon as possible to Cook for a credit.
FDA has yet to classify the severity of the recall. However, the potential complications from a tip splitting during a procedure include device fragments in the vascular system, which could then led to embolization to the heart or lungs, or occluding blood flow to end organs.
A list of affected catheters with Beacon Tip technology is available on FDA’s website.
The recall comes months after Cook suffered another major catheter recall involving 360 lots of single lumen central venous catheters and pressure monitoring sets and trays, or 17,827 devices globally. In that case, there was a potential for catheter tip fracture and/or separation. The company found that the technique used by the product assembler while adding the tip to the catheter likely contributed to the problem.
If you or a loved one have been affected by these catheters, contact the Attorneys at Chhabra & Gibbs, P.A. today by going to their website at http://cglawms.com or calling 601-948-8005.