August 19, 2014 — The U.S. Food and Drug Administration (FDA) has announced a Class I recall for the Diamondback 360 Peripheral Orbital Atherectomy System because pieces of the saline sheath can break off and obstruct blood vessels.
The Class I recall is the most serious type of recall, reserved for defective devices that have a good probability of causing severe injury or death. Fortunately, the Diamondback 360 system has not been linked to any injuries.
The device is used in a minimally-invasive surgery known as an atherectomy, which removes plaque from the inside of blood vessels. It is used in patients with serious atherosclerosis (narrowing of the arteries) who are at risk of heart attack and other life-threatening complications.
During the procedure, a surgeon inserts the Diamondback 360, a high-speed cutting tool, into the patient’s artery through a catheter. The system is intended to restore normal blood-flow through major arteries.
If pieces of the saline sheath break off, they can travel in the patient’s bloodstream and cause serious side effects. According to the FDA:
“Fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism).”
The manufacturer, Cardiovascular Systems, notified their customers of the recall on May 27. The recall affects products that were manufactured on May 8 and 9, 2014 and sold from May 16-20, 2014. The recall affects Model Number DPB-125MICRO145, Part number 7-10003, and Lot Numbers 100573, 100575, 100674, 100676, 100678, and 100680.
Do I have a Atherectomy Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting atherectomy induced injury cases in all 50 states. If you or somebody you know has been injured by this recalled device, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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