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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MCW
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