Cook Medical has issued a worldwide recall for its catheters after receiving complaints about the devices splitting or breaking apart while inside of patients.
Free Confidential Lawsuit Evaluation: If you have experienced a catheter-tip splitting and/or catheter-tip separation that seriously affected your health, or if your loved one died due to catheter malfunction, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Teleflex Catheters Recalled for Excess Material
June 26, 2017 - Teleflex subsidiary Vascular Solutions has issued a Class I Recall for its Venture Catheters due to the potential for excess material to be present within the inner lumen of the distal catheter tip. The material could separate from the catheter and cause serious injury due to embolism, according to the FDA.
What’s the Problem?
May 3, 2016 - Approximately 4.1 million catheters manufactured between March 2013 and March 2016 are affected by the recall, according to the U.S. Food & Drug Administration (FDA) [1]. Cook issued a recall for the same products twice last year - the company has seen an increase in complaints about the devices splitting, so it issued a global recall on all Beacon Tip catheters. The recall affects all unexpired lots of the Rapid Exchange, Over-the-Wire, and Coronary Sinus versions of Venture Catheters.
Tip splitting or separation can cause the catheter to stop working, the company said. After separating from the angiographic catheter, the tip could enter a patient’s bloodstream and cause serious injury requiring additional medical intervention to recover the tip, and may also cause death. The splitting or separation could block blood flow to end organs, according to the manufacturer.
“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,” said Pete Yonkman, president of Cook Medical.
Cook says it has notified customers and distributors of the recall by letter, which requests that all affected units be quarantined and returned to the company. A preliminary investigation found that environmental conditions may have contributed to the degradation. The company says the FDA and other regulatory agencies have been notified. Click on the following link to view a complete list of affected products (PDF).
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Do I Have a Cook Catheter Recall Lawsuit?
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cook catheter recall lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you’ve been injured by a catheter, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.
