Home / Recalls / Micro Therapeutics Inc, Dba Ev3 Neurovascular / Z-1453-2014

Z-1453-2014 Class I Terminated

Recalled by Micro Therapeutics Inc, Dba Ev3 Neurovascular — Irvine, CA

Recall Details

Product Type
Devices
Report Date
April 23, 2014
Initiation Date
April 1, 2014
Termination Date
October 31, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32 units total (23 units in US)

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.

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.

Code Information

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

Other recalls by Micro Therapeutics Inc, Dba Ev3 Neurovascular

  • Z-1528-2020 Class I — ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neu (February 14, 2020)
  • Z-1527-2020 Class I — ev3 Pipeline Flex Embolization Device. For neurological endovascular use. (February 14, 2020)
  • Z-3022-2018 Class II — ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XT (August 10, 2018)
  • Z-1701-2018 Class I — MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 3000 (February 26, 2018)
  • Z-0310-2017 Class I — X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-060 (October 5, 2016)
  • Z-0309-2017 Class I — Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Cathete (October 5, 2016)
  • Z-0308-2017 Class I — Alligator Retrieval Device The device is intended for use in the peripheral and (October 5, 2016)
  • Z-0307-2017 Class I — Pipeline Embolization Device (Pipeline Classic) The device is indicated for the (October 5, 2016)
  • Z-0120-2016 Class II — -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipelin (September 4, 2015)
  • Z-1454-2014 Class I — Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature f (April 1, 2014)