August 19, 2014 — Cardiovascular Systems is recalling the Diamondback 360 Peripheral Orbital Atherectomy System because it may have a defective saline sheath that can fracture during use, travel in the bloodstream (called an “embolism”), and potentially block blood vessels.
The Diamondback 360 is a high-speed cutting tool that is inserted via a catheter through the skin into a patient’s blood vessel. The system is designed to re-establish blood-flow in narrow arteries or arterio-venous dialysis shunts.
The device is used in patients undergoing an atherectomy, which is a minimally-invasive surgical method of removing plaque from blood vessels. It is usually done in major arteries, such as the coronary, carotid, and vertebral arteries.
According to the recall notification, :
“Fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism).”
Although no one has been injured, the U.S. Food and Drug Administration (FDA) has issued a Class 1 recall — the most serious type of recall, reserved for devices that have a reasonable probability of causing serious injury or death.
The recall affects 94 devices that were manufactured on May 8-9, 2014, including 40 devices that were sold from May 16-20, 2014.
Cardiovascular Systems notified their customers of the recall on May 27 with an “Urgent Medical Device Recall” notification. The recall affects Model Number DPB-125MICRO145, Part number 7-10003, and Lot Numbers 100573, 100575, 100674, 100676, 100678, and 100680.
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