Z-2155-2014Class I

CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number...

Name: Z-2155-2014 CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number...
Creator: Cardiovascular Systems, Inc.
Published: 2014-05-23
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2014-05-23 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems, Inc. began a recall of CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360... on 2014-05-23. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2155-2014
Classification: Class I
Status: Terminated
Initiated: 2014-05-23
Posted: 2014-08-14
Terminated: 2014-10-01
Recalling firm: Cardiovascular Systems Incorporated
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.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 100573, 100575, 100674, 100676, 100678, 100680.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2155-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2014	Class I	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code MCW

K133399Class IIDiamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems Incorporated / cleared 2013-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)