Cardiovascular Systems, Inc. recalls Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate sten…

Recall date

March 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1290-2015

FDA classification

Class I

Brand / firm

Cardiovascular Systems, Inc.

Sold / distributed

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

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.