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FDA ISSUES RECALL NOTICE ABOUT CARDIOVASCULAR SYSTEMS' DIAMONDBACK 360 BLOOD VESSEL TOOL

FDA ISSUES RECALL NOTICE ABOUT CARDIOVASCULAR SYSTEMS' DIAMONDBACK 360 BLOOD VESSEL TOOL

The FDA recently warned healthcare professionals of a recall of Diamondback 360 Peripheral Orbital Atherectomy Systems. This medical device is inserted into patients' blood vessels and used "to reestablish blood flow in narrowed arteries." Cardiovascular Systems has recalled certain lot numbers of the device since "they may contain defective saline sheaths that could fracture during use." The resulting fragments could in turn block the treated blood vessel or cause an embolism.

Cardiovascular Systems has sent an Urgent Medical Device Recall letter to its customers with instructions to "[r]emove affected devices from service". The initiated recall is Class I - the most serious type of recall used when "there is a reasonable probability... [of] serious adverse health consequences or death."

Sources:

FDA,

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm410527.htm

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm410449.htm

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