Recall Z-2155-2014 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems, Inc.
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 tr
| Date | Aug 14, 2014 (initiated May 23, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 48 |
| Distribution | Nationwide Distribution including AZ, AR, CA, CT, FL, IL, IA, MD, MI, NY, NC, PA, TN,and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133399 | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Cardiovascular Systems Incorporated, Nov 22, 2013 |