Recall Issued for Daimondback Devices
According to the U.S. Food and Drug Administration (FDA), Cardiovascular Systems Incorporated has recalled 142 Diamondback 360 Peripheral Orbital Atherectomy Systems due to a defective component that can fracture, resulting in the blockage of blood vessels.
About the Diamondback 360 Recall
The FDA recall notice notes that some of the units may contain defective saline sheaths which can fracture during use. Fragments from the fractured sheaths can block the blood vessel that is receiving treatment or may block surrounding blood vessels, putting patients at an increased risk of embolism.
Although no injuries have been reported as a result of the issue, the FDA has designated the recall as a Class I recall, denoting a problem that could potentially lead to serious injury or death.
Details of the Recalled Diamondback Devices
- The recall affects 94 of the devices made May 8 and May 9, and 48 devices distributed between May 16 and May 20.
- Any defective devices should be returned to the St. Paul, Minnesota headquarters.
- The recall affects model numbers DPB-125MICRO145 and part number 7-10003 from lots 100573, 100575, 100674, 100676, 100678 and 100680, according to the recall notice.