Devices

Device Recall Diamondback 360 Peripheral Orbital Atherectomy System.

Model / Serial
100573, 100575, 100674, 100676, 100678, 100680.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
Product Description
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. || The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Manufacturer
Cardiovascular Systems, Inc.
1 Event
- Recall of Device Recall Diamondback 360 Peripheral 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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