Medical Device Safety and Recalls: Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System

A recall has been issued for Cardiovascular Systems Diamondback 360 Peripheral Orbital Atherectomy System.  Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use.  If this happens, fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism).  There are no reported patient injuries to date.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm410449.htm

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