Recall Z-0309-2017— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2016-10-05, terminated 2017-10-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05. Reason: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream..

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Classification

Class I

Status

Terminated

Initiated

2016-10-05

Terminated

2017-10-11

Firm location

Irvine, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.