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U.S. Department of Health and Human Services

Class 3 Device Recall Diamondback 360 Coronary Orbital Atherectomy System

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  Class 3 Device Recall Diamondback 360 Coronary Orbital Atherectomy System see related information
Date Initiated by Firm January 27, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on May 05, 2014
Recall Number Z-1095-2014
Recall Event ID 67445
510(K)Number K071073  
Product Classification Catheter, coronary, atherectomy - Product Code MCX
Product CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125

Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Code Information Lot: 85408 -85412, 85585 -85587, 87276, 87278, 87280, 87317, 87462, 87464, 87793, 87949 - 87952, 88520 - 88524, 88975 - 88979, 89498, 89501- 89504, 89952, 89954, 89956, 91876, 91877, 91891, 92124, 92156.
Recalling Firm/
Manufacturer		 Cardiovascular Systems, Inc.
651 Campus Dr
Saint Paul MN 55112-3495
For Additional Information Contact Customer Service
877-274-0901
Manufacturer Reason
for Recall		 Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
FDA Determined
Cause 2		 Process control
Action Cardiovascular Systems Inc. sent an "Urgent Medical Device Recall" letter dated January 27, 2014 to all affected customers. The letter described the affected product, recall description and actions to be taken. Customers were instructed to complete and return the attached Customer Acknowledgement Form and return the device i available. For further information they should contact CSI Customer Service at 651 Campus Drive, Saint Paul, MN 55112, Tele 877-274-0901, Fax 612-677-3355.
Quantity in Commerce 318
Distribution USA Nationwide Distribution in the states of AZ, CA, FL, MA, MN, MS, NC, NJ, NY, PA, TN, TX, VA.
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 = MCX and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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