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.
This recall has been terminated (originally issued August 14, 2014).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- May 23, 2014
- Posted
- August 14, 2014
- Terminated
- October 1, 2014
- Recall Number
- Z-2155-2014
- Quantity
- 48
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Distribution
Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX.
Lot / Code Info
100573, 100575, 100674, 100676, 100678, 100680.
Root Cause
Process control
Action Taken
Cardiovascular System, Inc. sent consignees an Urgent Medical Device Recall letter dated May 23, 2014. The letter described the Affected Product, Recall Description, Instructions which included to remove the affected product and return it to CSI and to complete and return the Customer Acknowledgement Form. For further Information they customers were instructed to contact Customer Service, Cardiovascular System, Inc., 877-274-0901. For questions regarding this recall call 877-274-0901.