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
Product summary
- 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
mislabeled