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FDA designates recall of catheters as Class I

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The FDA has designated Vascular Solutions’ product recall of a line of catheters as a Class I recall, the most serious kind.

The recall affects 7,054 devices manufactured and distributed in the United States between May 2015 and April 2017, according to a safety alert from the agency.

The tip of the devices (Venture RX Catheter Model 5820, Venture OTW Model 5821, Venture CS Model 5822) may separate or split when directing and supporting a guidewire through veins and arteries or administering drugs or fluids into blood vessels. The separated material may enter a patient’s bloodstream, which may result in embolism, blood clots or death, according to the FDA.

Vascular Solutions distributed a recall letter in April 2017 to customers and distributors, informing them to return the recalled devices to the company. The company will issue a credit for returned devices, according to the FDA’s alert.