The U.S. Food and Drug Administration (FDA) has announced a class I recall of Angiodynamics Soft Vu Omni Flush Angiographic Catheters following reports of the tip of the catheter detaching from the main body. Separation of the tip can cause internal organ injury, stroke, kidney failure and other serious adverse consequences.

According to the FDA, Stryker Sustainability Solutions, the company that manufactures the catheter, sent letters to customers “informing them of the high possibility of tip separation during use” and recommends that health care professionals discontinue the use of the recalled catheters.

Read the FDA announcement. 

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Catheters, Renal Insufficiency, Stroke, United States Food and Drug Administration, Cardiac Surgical Procedures, Angiography, Diagnostic Imaging

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