Cook Medical has recalled 4.1 million Beacon Tip catheters because the tip can break off and cause severe injury or even death. This is the third time the tips have been recalled and more than 30 incidents have been reported.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting catheter induced injury cases in all 50 states. If you or somebody you know was injured by a recalled catheter that broke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
Cook Medical manufactures a variety of catheters with Beacon Tip® technology, a distinct radiopaque tip marker that can be easily seen on an X-ray. The tips are used on catheters that inject contrast dye into the heart of patients undergoing cardiac angiogram.
What is the problem?
A polymer in the Beacon Tip can break down and cause it to split or separate. Fragments of a broken catheter can travel in the bloodstream and cause major complications, including death. Serious complications include:
- Emergency heart surgery to remove the tip
- Damage to the vascular system, genitourinary system (bladder and kidneys), soft tissues, or other organs.
- Embolization of fragments to the heart or lungs
- Obstruction of blood-flow to vital organs
Cook Beacon Tip Catheter Recalls
In April 2016, Cook recalled about 4.1 million Beacon Tip catheters that were made between March 2013 and March 2016.
The action expands a recall that began in July 2015, when Cook issued a Class 1 recall for angiographic catheters. The company received 26 reports of the tip breaking, resulting in 14 adverse events.
In October 2015, the recall expanded worldwide after Cook received 42 reports of the tip breaking. The catheters were distributed globally from September 2012 to September 2015. Click here to read more.
Why Did Cook Recall Beacon Tip Catheters?
The problem is that a polymer in the Beacon Tip can degrade, which increases the risk of separation. A preliminary investigation by Cook traced the problem to environmental conditions, such as storage temperature, humidity, and the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within healthcare facilities.
What Products 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
Do I have a Cook Catheter Lawsuit?
The Schmidt Firm, PLLC is currently accepting catheter induced injury cases in all 50 states. If you or somebody you know was injured by a recalled catheter that broke, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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