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U.S. Department of Health and Human Services

Class 2 Device Recall Marathon Flow Directed Micro Catheter

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  Class 2 Device Recall Marathon Flow Directed Micro Catheter see related information
Date Initiated by Firm September 23, 2011
Date Posted September 27, 2012
Recall Status1 Terminated 3 on September 28, 2012
Recall Number Z-2472-2012
Recall Event ID 63188
510(K)Number K034036  
Product Classification Catheter, continuous flush - Product Code KRA
Product Marathon Flow Directed Micro Catheter, Model #105-5055.

Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Code Information Lot # 9374210
Recalling Firm/
Manufacturer		 Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact
949-839-3700
Manufacturer Reason
for Recall		 The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
FDA Determined
Cause 2		 Error in labeling
Action Micro Therapeutics Inc, Dba Ev3 Neurovascular sent a recall notification letter dated September 23, 2011 to all their affected customers. The letter identified the affected product, problem, and actions to be taken. The notification letter also provides the customer (physician) with appropriate information regarding the affected products. The letter instructs customer to stop using the affected product, segregate from inventory and return for replacement with conforming product. The notice requests the customer to complete and return the reply form indicating use or return of devices in the affected lot(s). Customers with questions regarding the recall letter were instructed to contact Kim Salceda at (949) 680-1305.
Quantity in Commerce 23 units total
Distribution Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
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 = KRA and Original Applicant = MICRO THERAPEUTICS, INC.
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