Recall Z-0505-2018 ยท MCW Catheter, Peripheral, Atherectomy
Cardiovascular Systems Inc
Peripheral Diamondback 1.25 Solid OAD, 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.
| Date | Sep 14, 2017 |
| Status | Terminated |
| Reason | Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production. |
| Root cause | Labeling mix-ups |
| Action | On 09/14/2017 the firm sent letters to their consignees explaining the recall and given the following instructions: Please immediately remove from use and return the affected Product Name devices to CSI. To do so: 1) Complete the attached Customer Acknowledgement Form a. Per lot, document the quantity of all devices that are to be returned. b. Per lot, document the quantity of all devices that have been consumed. 2) Place the Acknowledgement Form with the device 3) Return the device and Acknowledgement Form to CSI using the pre-paid FedEx label a. If you would like, a CSI Sales Representative |
| Quantity | 8 |
| Distribution | FL, IL, MI, MN, MO, NY, SC, TX, and WI |
| 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 |