FDA Class I Recall for Cardiovascular Systems Blood Vessel DeviceAug 21, 2014
The Food and Drug Administration (FDA) has announced the recall of certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems, model number DPB-125MICRO145 (part number 7-10003), made by St. Paul, Minnesota firm, Cardiovascular Systems Inc.
The device is a high-speed cutting tool used to “reestablish blood flow in narrowed arteries,” according to the FDA. The recalled devices may contain defective saline sheaths that could break during use and fragments of the sheath could block blood vessels.
The recalled devices are lots 100573, 100575, 100674, 100676, 100678, 100680. The 94 affected Diamondback 360 system devices were manufactured on May 8 and May 9, 2014; 48 devices were distributed between May 16 and May 20, 2014.
This recall is a Class I recall, the FDA’s most serious recall category, which the agency reserves for situations in which there is a reasonable probability that use of the device will cause serious adverse health consequences or death.
Cardiovascular Systems has sent an Urgent Medical Device Recall letter to customers who purchased the Diamondback 360 device. The letter identified the potential problem with the device and the specific products affected by the recall. The letter advised customers to pull the recalled devices from service and return them to the company. According to the FDA, no patient injuries have been reported to date.
Patients and health care professionals who have experienced adverse reactions or quality problems with the Diamondback 360 device are encouraged to report this to the FDA through the MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm.
Customers can contact Cardiovascular Systems customer service for more information at 1.877.274.0901.