Recall Z-0120-2016— Micro Therapeutics Inc, Dba Ev3 Neurovascular

Class II FDA medical device recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, initiated 2015-09-04, terminated 2017-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.. Reason: The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use..

Recalling firm

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Classification

Class II

Status

Terminated

Initiated

2015-09-04

Terminated

2017-05-18

Firm location

Irvine, CA, United States

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