Home / Recalls / Medical Devices
Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro C
Recalled October 3, 2012 · FDA recall Z-2471-2012 · Micro Therapeutics Inc,
Hazard
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 Class II
Units
36 units
Sold at
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.
Description
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.
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.
Manufacturer(s)
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →