Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Increased resistance reported with some of the devices has led to 10 injuries and one death.

Class I Recall for 330,000 Radial Artery Catheterization Kits: FDA

Device manufacturer Teleflex, and its subsidiary Arrow International, are recalling certain radial artery catheterization kits following reports of malfunction in both the guidewire handle and chamber leading to increased resistance, according to the US Food and Drug Administration.

With 10 injuries and at least one death related to this issue, the agency is classifying the action as a Class 1 recall, the most serious type.

The associated devices are the Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits which enable clinicians access to a patient’s peripheral arterial circulation or other small vessels. A total of 334,995 affected devices were distributed between December 2021 and January 2024.

“This issue may cause serious injury, including injury to blood vessel walls, narrowing of the blood vessels (vasospasm), artery blockage (embolism), or death,” according to the FDA.

The agency has received a total of 194 reports of increased resistance in the guidewire handle and chamber during use.

Teleflex initiated the recall on February 12, 2024, and advised medical facilities to immediately check inventory for product distributed within the recall period and return it to the manufacturer for a credit. Additionally, healthcare professionals and consumers are encouraged to report adverse events or problems with these devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting System.