The recall includes 262,016 Arrow Endurance Extended Dwell Peripheral Catheter Systems made by Teleflex and its subsidiary Arrow International.
The devices might separate or leak. If a catheter breaks while in a blood vessel, fragments could migrate throughout the body and cause the “blockage of blood vessels, inadequate blood flow, injury to blood vessel walls, blood clots, blockage of the lung arteries (pulmonary embolism)” and heart attacks, the FDA said.
On June 26, the FDA labeled the recall as Class I — the most serious type — because patients can be seriously injured or killed. Teleflex notified customers in mid-May, according to the agency.
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