Although no injuries have been reported as a result of the potential issue, the FDA said today that the recall is Class I, denoting a problem that could lead to serious injury or death.
Cardiovascular Systems won pre-market approval from the FDA in October 2013 for clearing calcium deposits from blood vessels using the Diamondback 360 peripheral orbital atherectomy device. The recall affects the 94 of the devices made May 8 and May 9, only 48 of which were distributed between May 16 and May 20, according to the FDA.
CSI sent an urgent recall letter to customers May 27, the federal watchdog agency said, identifying the problem and asking that any affected devices be removed from service and returned to the St. Paul, Minn.-based company. The affected Diamondback devices might have a defective saline sheath that could fracture, leaving fragments that could block either the treatment vessel or other vessels and cause an embolism, the FDA said.
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.