Device Recall Diamondback 360 Coronary Orbital Atherectomy System

Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.

Cardiovascular Devices

3

No

USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.

CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 || Product Usage: 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.