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U.S. Department of Health and Human Services

Class 2 Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy System

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  Class 2 Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy System see related information
Date Initiated by Firm September 14, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0506-2018
Recall Event ID 78897
510(K)Number K152694  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
Product 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.
Code Information Lot # 190217 Part #: 7-10011 Model # DBP-150SOLID145
Recalling Firm/
Manufacturer		 Cardiovascular Systems Inc
1225 Old Highway 8 NW
Saint Paul MN 55112-6416
For Additional Information Contact Field Action Hotline
651-259-2800
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 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: csifieldactionhotline@csi360.com 651-259-2800 - Tel
Quantity in Commerce 8
Distribution FL, IL, MI, MN, MO, NY, SC, TX, and WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = Cardiovascular Systems Inc.
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