FDA Issues Early Alert: Arrow Guidewire Coating May Detach Into the Bloodstream, Catheter Products Removed
WASHINGTON — The U.S. Food and Drug Administration (FDA) issued an Early Alert on November 10 about a potentially high-risk medical device issue: Arrow International, a subsidiary of Teleflex Incorporated, has sent a letter to affected customers recommending that certain products containing Spring Wire Guide components be removed from where they are used or sold. The FDA said it is reviewing the issue and will update the public as significant new information becomes available.
Affected products include the Arrow Marked Guidewire in hydrophilic-coated nitinol and stainless steel versions, and a range of pressure-injectable catheters containing those guidewires, including one-, two- and three-lumen PICC products in the Arrowg+ard Blue Advance line and related kits. Arrow coated guidewires help place catheters in blood vessels, and the affected catheters are used to deliver medicines and fluids and to collect blood samples.
According to the FDA, Arrow International stated there is a potential quality issue with the supplied hydrophilic-coated Spring Wire Guide components: Teleflex confirmed the coating may swell inconsistently when hydrated with saline, leading to clumping of the coating and potential detachment. Detachment could release particles into the bloodstream, increasing the risk of emboli, and hydrophilic polymer emboli may have adverse health consequences including inflammation, thrombosis, ischemia, tissue injury, stroke, further intervention, or death.
On November 5, Arrow International sent all affected customers a letter recommending they immediately check inventory, cease use and distribution of affected product and quarantine it, contact Teleflex Customer Service to return it, and provide a copy of the recall notice to all customers who received impacted product. As of November 5, the company had reported no serious injuries or deaths associated with the issue.
Customers in the U.S. with adverse reactions, quality problems, or questions should contact Arrow International at [email protected] or 1-866-396-2111. Health care professionals and consumers may also report problems through the FDA's MedWatch program.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
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