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U.S. Department of Health and Human Services

Class 1 Device Recall Diamondback 360 Coronary Orbital Artherctomy System

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  Class 1 Device Recall Diamondback 360 Coronary Orbital Artherctomy System see related information
Date Initiated by Firm March 04, 2015
Date Posted March 20, 2015
Recall Status1 Terminated 3 on April 26, 2016
Recall Number Z-1290-2015
Recall Event ID 70727
PMA Number P130005 
Product Classification Catheter, coronary, atherectomy - Product Code MCX
Product Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125.

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 107046, 106992, 106993, 106990.
Recalling Firm/
Manufacturer		 Cardiovascular Systems, Inc.
651 Campus Dr
Saint Paul MN 55112-3495
For Additional Information Contact Megan Brandt
651-259-2805
Manufacturer Reason
for Recall		 The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent on 3/4/2015 a CSI "Urgent Medical Device Recall" letter dated March 04, 2015. The letter described the problem and the affected product. Consignees were advised to remove and return the affected product to CSI. The letter also requested consignees to complete and return the Customer Acknowledgement Form by Fax or with the RGA (Returned Goods Authorization). For further information they can contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton, MN 55112, 877-274-0901 -Tel, 612-677-3355- Fax.
Quantity in Commerce 30
Distribution Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
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.
PMA Database PMAs with Product Code = MCX and Original Applicant = CARDIOVASCULAR SYSTEMS, INC.
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