Recall Z-1230-2017 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems Inc
DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot a
| Date | Feb 22, 2017 (initiated Dec 7, 2016) |
| Status | Terminated |
| Reason | CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. |
| Root cause | Employee error |
| Action | Cardiovascular Systems, Inc. sent an Urgent Medical Device Recall letter, dated 12/07/2016, to all affected customers. The letter identified affected product , stated the reason for recall, asked for product to be returned to CSI. Questions can be directed to Customer Service at 877-274-0901. |
| Quantity | 8 units |
| Distribution | Nationwide Distribution to LA, MS, SC, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152694 | Diamondback 360 Peripheral Orbital Atherectomy System Cardiovascular Systems, Inc., Oct 21, 2015 |