Arrow QuickFlash Catheterization Kit Recall Issued Following Reports of Life-Threatening Blood Vessel Damage
At least 10 patient injuries and one death have been reported in connection to the Arrow QuickFlash catherization kit recall.
Federal safety officials warn that problems with the guidewire handles on ARROW catheterization kits could lead to serious and potentially life threatening damage to blood vessels, leading to the recall of more than 330,000 devices distributed throughout the United States between December 2021 and January 2024.
The ARROW QuickFlash Catheterization Kits recall was posted by the U.S. Food and Drug Administration (FDA) on April 3, after the manufacturer received reports of at least 194 complaints, including 10 severe injuries and one death that appears to be related to the problem.
The recalled ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits are designed for medical professionals to gain entry into a patient’s peripheral arterial system or smaller blood vessels. However, officials warn that increased resistance in the guidewire handle and chamber during use may lead to severe harm, including damage to the walls of blood vessels, constriction of blood vessels (known as vasospasm), blockages in arteries (embolism), or even fatalities.
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This recall affects approximately 334,995 Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits that were distributed from December 1, 2021, to January 27, 2024.
In a recall letter sent out to medical facilities and distributors on February 12, the manufacturers instructed medical facilities to immediately stop using and distributing the devices and to quarantine any remaining inventory. They advised distributors to provide a copy of the recall letter to customers who have purchased the recall products, and an acknowledgement that must be completed by customers.
Any customers with any questions or concerns are advised to contact Teleflex and Arrow International at their Customer Service Phone: 1-866-396-2111, FAX: 1-855-419-8507 or Email: Recalls@teleflex.com.
The FDA is allowing consumers to report any adverse reactions, side effects, or quality issues encountered during the use of these kits to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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