Cardiovascular Systems recalled certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly cause an embolism which might block the blood vessel under treatment or blood vessels further away.
The Diamondback 360 Peripheral Orbital Atherectomy System, model DPB-125MICRO145, is a high-speed cutting tool inserted via a catheter through the skin into a patient’s blood vessel. The system is used to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. It is intended for patients who are acceptable candidates for procedures to open up blocked blood vessels using catheters with balloons (percutaneous transluminal angioplasty).
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
Lot numbers 100573, 100575, 100674, 100676, 100678 and 100680 are being recalled. Ninety-four affected devices were manufactured from May 8, 2014, to May 9, 2014. Forty-eight devices were distributed from May 16, 2014, to May 20, 2014.
See the Recall
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