Device Recall Diamondback 360 Peripheral Orbital Atherectomy System.

100573, 100575, 100674, 100676, 100678, 100680.

Cardiovascular Devices

2

No

Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.

CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. || The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.