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Recall Observatory FDA recall evidence

Device product

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.

Z-2471-2012

September 23, 2011

Class II

Product summary

Firm
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Event
Event 63188
Status
Terminated
Classification
Class II
Quantity
36 units
Official record key
device-enforcement:Z-2471-2012

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 # 9374298

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