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Recall Observatory FDA recall evidence

Device 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.

Z-2472-2012

September 23, 2011

Class II

Product summary

Firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Event
Event 63188
Status
Terminated
Classification
Class II
Quantity
23 units total
Official record key
device-enforcement:Z-2472-2012

Official wording

Reason: 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.

Code information: Lot # 9374210

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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled