Class 1 Device Recall Diamondback 360 Peripheral Orbital Atherectomy System.

• Date Initiated by Firm: May 23, 2014
• Date Posted: August 14, 2014
• Recall Status: Terminated on October 01, 2014
• Recall Number: Z-2155-2014
• Recall Event ID: 68806
• 510(K)Number: K133399
• Product Classification: Catheter, peripheral, atherectomy - Product Code MCW
• Product: 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.
• Code Information: 100573, 100575, 100674, 100676, 100678, 100680.
• Recalling Firm/ Manufacturer: Cardiovascular Systems, Inc.; 651 Campus Dr; Saint Paul MN 55112-3495
• For Additional Information Contact: Customer Service; 877-274-0901
• Manufacturer Reason for Recall: CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
• FDA Determined Cause: Process control
• Action: Cardiovascular System, Inc. sent consignees an Urgent Medical Device Recall letter dated May 23, 2014. The letter described the Affected Product, Recall Description, Instructions which included to remove the affected product and return it to CSI and to complete and return the Customer Acknowledgement Form. For further Information they customers were instructed to contact Customer Service, Cardiovascular System, Inc., 877-274-0901. For questions regarding this recall call 877-274-0901.
• Quantity in Commerce: 48
• Distribution: Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and 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