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U.S. Department of Health and Human Services

Class 2 Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy System

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  Class 2 Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy System see related information
Date Initiated by Firm December 07, 2016
Date Posted February 22, 2017
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-1230-2017
Recall Event ID 76352
510(K)Number K152694  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
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.
Code Information Lot: 171686, Expiration: 2018-09-30
Recalling Firm/
Manufacturer		 Cardiovascular Systems Inc
1225 Old Highway 8 NW
Saint Paul MN 55112-6416
For Additional Information Contact Customer Service
877-274-0901
Manufacturer Reason
for Recall		 CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
FDA Determined
Cause 2		 Employee error
Action Cardiovascular Systems, Inc. sent an Urgent Medical Device Recall letter, dated 12/07/2016, to all affected customers. The letter identified affected product , stated the reason for recall, asked for product to be returned to CSI. Questions can be directed to Customer Service at 877-274-0901.
Quantity in Commerce 8 units
Distribution Nationwide Distribution to LA, MS, SC, TX
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = Cardiovascular Systems Inc.
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