Devices

Device Recall Diamondback 360 Coronary Orbital Atherectomy System

Model / Serial
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.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
Product Description
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.
Manufacturer
Cardiovascular Systems, Inc.
1 Event
- Recall of Device Recall Diamondback 360 Coronary Orbital Atherectomy System

Manufacturer

Cardiovascular Systems, Inc.

Manufacturer Address
Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
Manufacturer Parent Company (2017)
Cardiovascular Systems, Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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