On Monday, medical device manufacturer Cook Medical issued a voluntary recall of more than 4 million catheters. This is actually a follow-up recall, as the company previously issued four recalls, covering more than 400,000 catheters. It is the largest recall in Cook Medical history. These catheters are typically used for vascular procedures like minimally-invasive urology or reproductive surgery.
The recalls were triggered when the company received numerous reports of tips splitting or breaking, which meant surgeons had to go in and remove them. While to date no patients have died because of these defective products, they have received dozens of reports and in at least 30 cases, surgeons were forced to use a snare device to retrieve the broken tips during the removal procedure.
Cook said it was conducting an investigation to determine exactly what had been causing the catheters to fail. In their announcement, they noted that the vast majority of complaints were received from a few hospitals, where professionals discovered that the tungsten and nylon tips were degrading. The tips used what the company refers to as “Beacon Tip” technology.
The reports of problems seemed so isolated that it appeared unlikely the catheters were shipped with defects as a result of assembly or faulty materials, according to Cook. One possible problem that was found when Cook’s internal investigators went into these hospitals. Apparently, many of them had implemented new sterilization technologies that used vaporized hydrogen peroxide to clean operating rooms. These procedures were implemented whenever patients were infected with what are referred to as “superbugs,” which are extremely resistant bacteria like MRSA, or methicillin-resistant staphylococcus. The investigators learned that the Cook Medical catheters had been left in the operating room during the sterilization process.
The company plans to conduct a root cause analysis to find out whether or how the new whole-room sterilization technologies may be impacting the quality of the catheters, or may be causing them to deteriorate.
This latest catheter recall just adds to Cook Medical’s problems, as the company is also dealing with hundreds of lawsuits by patients alleging that some of their medical devices harmed them. Among these devices include IVC filters that are used to prevent blood clots from reaching the heart or lungs. In many cases these filters broke apart and surgery was required to remove them.
If you or a loved one has been injured or suffered a wrongful death because of a catheter, an IVC filter or any other medical decide that failed in some way, please contact the Medical Device Injury Attorney at the Hill Law Firm as soon as possible, so that we can investigate and help you protect your rights and get you the compensation you deserve.