Cardiovascular Systems Inc recalls DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimal

Recalled March 1, 2017 · FDA recall Z-1230-2017 · Cardiovascular Systems

Hazard

CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. · FDA Class II

Units

8 units

Sold at

Nationwide Distribution to LA, MS, SC, TX

Description

CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.

Product

DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs 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. The Stealth 360 Orbital PAD 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.

Manufacturer(s)

Cardiovascular Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →