Micro Therapeutics Inc, Dba Ev3 Neurovascular recalls Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal c

Recalled April 23, 2014 · FDA recall Z-1453-2014 · Micro Therapeutics Inc,

Hazard

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

Units

32 units total (23 units in US)

Sold at

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.

Description

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

Product

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

Manufacturer(s)

Micro Therapeutics Inc, Dba Ev3 Neurovascular

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →