Peripheral Diamondback 1.50 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.

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.

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 can return the device and form. Please contact the CSI Recall Coordinator to organize pick up and return of the product. If all products specified in this recall notice have previously been consumed, used or are no longer available for return to CSI, please complete the Customer Acknowledgment Form per the above, and return the form to CSI in the provided FedEx envelope. Contact Information: [email protected] 651-259-2800 - Tel