Covidien responds to FDA safety alert for Onyx liquid embolic product

Covidien is facing some FDA scrutiny regarding its Onyx liquid embolic system, which is used to block blood flow in abnormally formed blood vessels in the brain before they're removed surgically. Regulators issued a safety alert for the product after receiving reports of 100 adverse events, with 9 patient deaths among them that are possibly connected, Mass Device reported. The product, manufactured by the company's ev3 subsidiary, has led to a catheter becoming stuck in the implanted Onyx material in some cases, according to the FDA. Regulators have subsequently approved labeling changes to encourage precautionary measures that reduce risks. A Covidien spokesman, meanwhile, told FierceMedicalDevices that "the safety and well-being of our customers is of the utmost importance to us. We are currently communicating with our customers and have taken the appropriate steps with the FDA to ensure that this matter is corrected immediately." Story

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