Recall Z-1453-2014— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Name: FDA recall Z-1453-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-01

Class I · Terminated

Class I FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2014-04-01, terminated 2014-10-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.. Reason: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire..

Recalling firm: Micro Therapeutics Inc, Dba Ev3 Neurovascular
Classification: Class I
Status: Terminated
Initiated: 2014-04-01
Terminated: 2014-10-31
Firm location: Irvine, CA, United States

Product description

Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.

Reason for recall

Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

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