BLOOMINGTON, IN — Cook Medical is recalling nearly 40,000 angiographic catheters in the United States after reports that the catheter tip may break off or split[1]. If this happens, the tip could enter the patient's bloodstream, resulting in serious injury or death. Tip splitting or separation may also cause the device to stop working.
Cook Medical has received 26 reports of the device malfunctioning, with 14 resulting in reports of adverse events (the adverse events reported were not described).
The following angiographic catheters are being recalled:
Beacon Tip Torcon NB Advantage Catheters.
Beacon Tip Royal Flush Plus High-Flow Catheters.
Slip-Cath Beacon Tip Catheters.
A total of 38,895 catheters are being recalled in the US. The catheters were manufactured from May 9, 2013, to September 1, 2014, and distributed from June 6, 2013, to June 25, 2015.
A complete list of lot numbers is available here.
In a July 2 recall letter, Cook Medical instructed customers to immediately quarantine unused products from their inventory and return all unused products to the company as soon as possible.
An angiographic catheter is used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram.
For more information, customers can contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Time.
More information about today's recall is available on the FDA website.
To report problems with angiographic catheters, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online; with postage-paid FDA form 3500, available at https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
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Cite this: Beacon Tip Angiographic Catheters Recalled - Medscape - Aug 07, 2015.
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