Micro Therapeutics Inc, Dba Ev3 Neurovascular: Medical Device Recall in 2014 - (Recall #: Z-1453-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 1, 2014

Date Posted: April 23, 2014

Recall Number: Z-1453-2014

Event ID: 67893

Reason for Recall:

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

Status: Terminated

Product Quantity: 32 units total (23 units in US)

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated