In April 2016, Cook Medical initiated a worldwide recall for 4.1 million catheters because the Beacon Tip can fracture or separate. At least 30 incidents have been reported, according to the FDA.
Need a Texas Cook Catheter Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a defective Cook Beacon Tip Catheter, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Cook Beacon Tip Angiographic Catheters are tubes that inject contrast dye into blood vessels in the heart to prepare patients for a cardiac angiogram, which is a type of X-ray for the heart. The catheter is inserted through a small incision in the skin. It is placed into the blood vessel along a guide wire before injecting the contrast dye.
What is the problem?
The catheter tips can degrade, split, or separate. If a broken piece of the catheter enters a patient’s bloodstream during a procedure, it could cause serious injury or death. The potential complications include:
- Emergency heart surgery to retrieve the tip.
- Broken tips damage blood vessels, genitourinary system, or soft tissues.
- Fragments travel in the bloodstream and into the heart or lungs, obstructing blood-flow to vital organs.
Cook Beacon Tip Catheter Recall
April 15, 2016 — Cook Medical has recalled all 4,146,309 catheters with Beacon® Tip technology made between March 2013 and March 2016. Cook recalled angiographic catheters with Beacon Tip twice last year, but continued to receive complaints. The company has expanded the recall to include all types of catheters with the Beacon Tip.
What is Causing the Problem?
In a statement, Cook medical explained what they believe is causing the polymer tips to degrade:
“The preliminary investigation into this matter has identified that environmental conditions, such as storage temperature, humidity, the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence.”
Previous Recalls for Beacon Tip Catheters
In July 2015, Cook initiated a Class 1 recall for Beacon Tip Angiographic Catheters after receiving 26 reports of the catheter-tip breaking, with 14 serious injuClick here to read more.ries reported. Click here to read more
In October 2015, Cook expanded the recall worldwide after receiving 42 reports of tip splitting or separation. The products were distributed globally between September 2012 and September 2015.
What Catheters Were Recalled?
- Beacon® Tip Angiographic Catheters
- Torcon NB® Advantage Beacon® Tip Catheters
- Royal Flush® Plus Beacon® Tip High-Flow Catheters
- Slip-Cath® Beacon® Tip Hydrophilic Catheters
- Shuttle® Select Slip-Cath® catheters
- FluoroSet® Radiographic Tubal Assessment Set
- Haskal Transjugular Intrahepatic Portal Access Set
- Kumpe Access Catheter
- Liver Access and Biopsy Needle Set
- Neff D’Agostino Percutaneous Access Set
- Aprima™ Access Nonvascular Introducer Set
- Selective Salpingography Catheter with Beacon® Tip
- Transluminal Biliary Biopsy Forceps Set
- White Lumax® Guiding Coaxial Catheter
- Click here for a complete list
Need a Cook Catheter Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Cook catheter lawyers for a free lawsuit review.