Cardiovascular Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1290-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

Product Classification:

Class I

Date Initiated: March 4, 2015

Date Posted: April 1, 2015

Recall Number: Z-1290-2015

Event ID: 70727

Reason for Recall:

The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.

Status: Terminated

Product Quantity: 30

Code Information:

107046, 106992, 106993, 106990.

Distribution Pattern:

Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.

Voluntary or Mandated:

Voluntary: Firm initiated