Cook Medical Says Its Beacon Tip Angiographic Catheters Tip Has The Potential To Break Or Split And Cause Serious Injuries.
Citing safety concerns for patients worldwide, Cook Medical issued a voluntary Beacon Tip catheter recall for about 4.1 million catheters due to complaints over tips splitting or fracturing. There have been no reports of patient deaths due to the device malfunction or patients sent home with tips inside them, the Indianapolis Business Journal (IBJ) reported. However, there have been at least 30 catheter injury cases in which doctors retrieved the tips with a snare device, according to the IBJ report.
Cook Medical’s global, voluntary recall includes all lots and sizes of catheters with the Beacon Tip technology. The latest recall is the largest in recent years for Cook Medical. According to the company, catheters with Beacon Tip technology have been found to exhibit polymer degradation of the catheter tip which leads to either tip fracture or separation. Pete Yonkman, president of Cook Medical and Cook Group, said the company is not quite sure why the devices are failing. “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.” Catheter polymer degradation may cause the device to stop working or lead to medical intervention to remove a fragment of the device that has separated, according to the company.
“Fragments of the device left in patients can cause life-threatening complications including blocking blood flow to major organs.” – Southern Med Law
Southern Med Law is currently investigating Beacon Tip Angiographic Catheter recall lawsuit claims. If you or a loved one have been seriously injured by Beacon tip splitting or Beacon tip separation or if your loved one died as a result of the medical device’s malfunction, please contact the medical device litigation attorneys at Southern Med Law for a free evaluation of your claim. To speak with one of our lawyers, please call 205-547-5525 or visit www.southernmedlaw.com for more information on the catheter recall and to fill out our online contact form.
Angiographic catheters are used to inject contrast dye into blood vessels in the heart in preparation for a type of X-ray used to diagnose heart conditions. Cook makes about 1.5 million Beacon Tip catheter tips a year, according to the IBJ. In early 2015, Cook recalled about 96,000 Beacon Tip catheters and expanded the number to 408,000 in October. In 2014, Cook recalled 696 vascular retrieval snare devices which required medical intervention in four cases, the IBJ reported.
In addition to issues with its Beacon Tip catheters, court documents indicate that Cook Medical is facing lawsuits over its Inferior Vena Cava (IVC) filters. Retrievable IVC filters are small, spider-like devices implanted into the inferior vena cava to prevent blood clots. The lawsuits, consolidated in the U.S. District Court, Southern District of Indiana, contend that the devices cause serious injuries to patients due to fracturing, tilting, migrating, and failing to capture potentially deadly blood clots. (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation –MDL 2570)
Southern Med Law Is a Full Service Law Firm Providing Legal Representation To Men and Women across the country in lawsuits who were victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
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