Product News and Recalls

Cook Catheters Receive Class I Recall

cook catheters receive Class I recallGlobal medical device manufacturer Cook Medical has issued a Class I recall of its Beacon Tip Angiographic Catheters. According to a recent U.S. Food and Drug Administration (FDA) communication, the tips of the catheters may split or separate from the device, leading to serious injury or even death.

In addition to catheters, Cook is well known for its Celect and Gunther Tulip inferior vena cava (IVC) filters. These devices, which are intended to prevent cardiovascular complications by catching blood clots before they reach vital organs, have lately become the focus of a request for centralization into a federal multidistrict litigation. Plaintiffs in Cook IVC filter lawsuits allege that Cook’s Celect and Gunther Tulip IVC filters are defectively designed, with a tendency to fracture or migrate while inside the body and cause serious harm or death. Cook IVC filters have also been found to have a high incidence of vena caval perforation.

Cook’s Beacon Tip Angiographic Catheters are used in certain medical imaging procedures (angiography) to help visualize the inside of blood vessels and organs. The catheters are inserted through a small puncture in the skin and used to inject a contrast agent, which enhances x-ray imaging of the arteries and veins.

Cook initiated the Class I recall on July 2, requesting the return of over 2,000 lots of Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters. Cook cited complaints that the tips of the recalled catheters had split or separated from the rest of the device, sometimes entering a patient’s blood stream. This has the potential to seriously injure patients, and in some cases could prove fatal. Tip splitting or separation may also cause the catheter to stop working. According to the FDA, Cook received 26 reports of catheter malfunction, 14 of which included an adverse event.

Class I recalls are the most serious type of FDA recalls, and are issued when a drug or device is found to have a reasonable probability of causing severe injury or death.

Patients should be able to feel confident in the medical devices they are treated with. If you or some you know was injured by a defective Cook medical device such as a Celect or Gunther Tulip IVC filter, contact the lawyers at Lopez McHugh today to receive your free consultation.