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FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

FDA ISSUES RECALL NOTICE ABOUT COOK MEDICAL'S ANGIOGRAPHIC CATHETERS

By Kaiser Gornick LLP posted in Defective Medical Devices on Monday, August 17, 2015

The FDA recently warned healthcare professionals of a recall of Beacon Tip Angiographic Catheters by Cook Medical. These angiographic catheters "are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions." In the US alone, Cook Medical has recalled over 38,000 of these medical devices that were distributed between June 2013 and June 2015. The reason for the global recall is a faulty catheter tip that can dislodge and enter the patient's bloodstream. This in turn may require "additional medical intervention to retrieve the tip" and could lead to a serious injury or death. Cook Medical has received dozens of reports of device malfunctioning and 14 reports of adverse events.

Cook Medical has sent an Urgent Medical Device Recall letter with safety instructions to its customers. The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability that use of [the faulty devices] will cause serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457663.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm

Cook Medical

https://www.cookmedical.com/newsroom/cook-medical-issues-global-recall-of-beacon-tip-angiographic-catheter-products/

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