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U.S. Department of Health and Human Services

Enforcement Report - Week of April 23, 2014

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Product Detail

Product Description Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Recall Number Z-1453-2014
Classification Class I
Code Info PED Model/ Lot FA7735014 / 9879718 FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429 FA7742518 / 9856431 FA7730010 / 9869991 FA7737514 / 9855933 FA7742518 / 9860762 FA7732514 / 9873854 FA7737516 / 9858010 FA7745014 / 9874111 FA7735014 / 9855265 FA7740016 / 9859214 FA7745016 / 9879736 FA7735014 / 9875267 FA7740016 / 9879180 FA7747514 / 9868888
Product Distributed Qty 32 units total (23 units in US)
Reason For Recall Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.

Event Detail

Event Id 67893
Product Type Devices
Status Ongoing
Recalling Firm Micro Therapeutics Inc, Dba Ev3 Neurovascular
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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