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U.S. Department of Health and Human Services

Class 2 Device Recall Launcher Coronary Guiding Catheter

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  Class 2 Device Recall Launcher Coronary Guiding Catheter see related information
Date Initiated by Firm June 12, 2013
Date Posted June 21, 2013
Recall Status1 Terminated 3 on November 19, 2013
Recall Number Z-1564-2013
Recall Event ID 65458
510(K)Number K103386  K021256  
Product Classification Catheter, percutaneous - Product Code DQY
Product Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F

Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.
Code Information Model # LA8EBU45SH, Lot # 0006722866 and Model # LA6IMAD, Lot # 0006724224.
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall		 Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the catheters contained within each package.
FDA Determined
Cause 2		 Labeling mix-ups
Action Medtronic "Urgent Field Safety Notice" letter dated June 2013 to all affected customers. The letter described the affected product, problem and actions to be taken. The letter instructed customers to remove and quarantine all affected product within their inventory and return the affected product to Medtronic. For questions contact your local Medtronic representative.
Quantity in Commerce 15
Distribution Internationally distributed: to countries of Germany and Poland.
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 = DQY and Original Applicant = MEDTRONIC INC.
510(K)s with Product Code = DQY and Original Applicant = MEDTRONIC VASCULAR
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