Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc. is recalling 30 units of the Diamondback 360 Coronary Orbital Atherectomy System because the outer layer may flake off, potentially causing a flow-limiting embolism.
- Product
- 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 arter
- Category
- Medical Device
- Distribution
- Distributed nationwide