Teleflex and Arrow International Recall Arrow QuickFlash Radial Artery Catheterization Kits Due to Potential Guidewire Defect and Risk of Serious Injury or Death

Core Concepts

Teleflex and its subsidiary Arrow International have recalled the Arrow QuickFlash radial artery and radial artery/arterial line catheterization kits due to a potentially defective component that could cause arterial vasospasm and vessel injury, posing a serious risk of injury or death.

Abstract

Teleflex and its subsidiary Arrow International have recalled the Arrow QuickFlash radial artery and radial artery/arterial line catheterization kits. The recall is due to reports of increased resistance in the guidewire handle and chamber during use, which could cause arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type, due to the risk for serious injury or death. To date, the manufacturer has received 194 reports, including a total of 10 injuries and one death related to this issue.
The recall includes 334,995 kits distributed in the United States between December 1, 2021 and January 27, 2024. Affected customers are instructed to identify and quarantine any recalled kits, and complete and return the acknowledgement form by fax or email. Customers with any recalled kits will be contacted by a customer service representative who will provide a return goods authorization (RGA) number and instructions for returning the product.

Stats

Teleflex and Arrow International have received 194 reports, including a total of 10 injuries and one death related to this issue.
The recall includes 334,995 kits distributed in the United States between December 1, 2021 and January 27, 2024.

Quotes

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Key Insights Distilled From

Arrow QuickFlash Radial Artery Catheterization Kits Recalled

by Megan Brooks at www.medscape.com 04-03-2024

https://www.medscape.com/viewarticle/arrow-quickflash-radial-artery-catheterization-kits-recalled-2024a10006cd

Deeper Inquiries

What other medical devices or procedures may be affected by similar guidewire defects, and what steps are being taken to ensure patient safety across the industry?

Guidewire defects can potentially impact various medical devices and procedures that rely on guidewires for insertion or navigation, such as central venous catheterization, coronary angiography, and percutaneous transluminal coronary angioplasty (PTCA). To ensure patient safety across the industry, regulatory bodies like the FDA closely monitor adverse events and issue recalls when necessary. Manufacturers are encouraged to conduct thorough quality control checks, implement robust testing procedures, and provide comprehensive training to healthcare professionals on the proper use of medical devices.

What underlying design or manufacturing issues led to the defect in the Arrow QuickFlash kits, and how can Teleflex and Arrow International prevent similar problems in the future?

The defect in the Arrow QuickFlash kits, specifically the increased resistance in the guidewire handle and chamber, likely stemmed from issues in the design or manufacturing process. Potential factors could include material quality, assembly techniques, or inadequate testing protocols. To prevent similar problems in the future, Teleflex and Arrow International should conduct a detailed root cause analysis to identify the specific flaws. They should then implement corrective actions such as redesigning the component, enhancing quality control measures, and providing additional training to employees involved in the manufacturing process.

How can healthcare providers and patients be better informed about the risks and proper use of radial artery catheterization kits to minimize the potential for injury, even with non-defective products?

Healthcare providers and patients can be better informed about the risks and proper use of radial artery catheterization kits through comprehensive training programs, educational materials, and clear labeling on the product packaging. Teleflex and Arrow International should collaborate with healthcare organizations to conduct workshops, webinars, and informational sessions on the safe and effective use of these kits. Additionally, they can develop user-friendly guides and instructions that highlight potential risks, proper insertion techniques, and steps to take in case of complications. By enhancing awareness and education, both healthcare providers and patients can minimize the potential for injury associated with radial artery catheterization kits, even when the products are not defective.