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.
FDA Recall Z-2155-2014 · Posted 2014-08-14
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Recalling FirmCardiovascular Systems, Inc.
Recall StatusTerminated
Product CodeMCW
Date Initiated2014-05-23
Date Terminated2014-10-01
Product Quantity48
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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