Cardiovascular Systems, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2155-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: May 23, 2014

Date Posted: August 20, 2014

Recall Number: Z-2155-2014

Event ID: 68806

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.

Status: Terminated

Product Quantity: 48

Code Information:

100573, 100575, 100674, 100676, 100678, 100680.

Distribution Pattern:

Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.

Voluntary or Mandated:

Voluntary: Firm initiated