DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy Sy...
FDA Recall #Z-1230-2017 — Class II — December 7, 2016
Product Description
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.
Reason for Recall
CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Recalling Firm
Cardiovascular Systems Inc — Saint Paul, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8 units
Distribution
Nationwide Distribution to LA, MS, SC, TX
Code Information
Lot: 171686, Expiration: 2018-09-30
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.