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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Event Detail

Event ID 63188
Product Type Devices
Status Completed
Recalling Firm Micro Therapeutics Inc, Dba Ev3 Neurovascular
City Irvine
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-23
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access 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. Lot # 9374298 Class II 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. 36 units Z-2471-2012
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. Lot # 9374210 Class II 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. 23 units total Z-2472-2012
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