FDA Update: Peripheral Orbital Atherectomy System Recalled

The Food and Drug Administration (FDA) has notified health care professionals that certain lots of the Diamondback 360 Peripheral Orbital Atherectomy System have been recalled by the manufacturer, Cardiovascular Systems, due to concerns about saline sheaths fracturing during use. Blood vessels could be blocked by fragments of the sheath; however, the FDA noted that there haven't been any patient injuries to date.

Read the full FDA Safety Alert.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery

Keywords: Atherectomy, United States Food and Drug Administration

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