Micro Therapeutics Inc, Dba Ev3 Neurovascular: Medical Device Recall in 2015 - (Recall #: Z-0120-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

-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.

Product Classification:

Class II

Date Initiated: September 4, 2015

Date Posted: October 21, 2015

Recall Number: Z-0120-2016

Event ID: 72165

Reason for Recall:

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.

Status: Terminated

Product Quantity: 23 devices

Code Information:

Pipeline Model Number Lot Number FA-77250-16V06 9724629 FA-77350-16V10 A024276 FA-77350-16V12 A012865 FA-77350-18Vl0 A013596 FA-77350-20V12 A012039 FA-77375-14V12 A013029 FA-77375-16Vl2 A011629 FA-77375-16Vl2 A029223 FA-77375-16Vl2 A031361 FA-77375-18V10 A024213 FA-77375-20Vl2 A029315 FA-77400-14V12 A012885 FA-77425-18V12 A026942 FA-77450-14V12 A013028 FA-77475-20Vl2 A012383 FA-77500-16Vl2 A029316 Pipeline Flex Model Number Lot Number PED-400-20VO1 9977371 PED-475-20V01 A047151 PED-375-18V01 9971250

Distribution Pattern:

US Distributions to states of: TN, KY, VA, WI, MO, IL, UT, OR, and MD. No foreign consignees.

Voluntary or Mandated:

Voluntary: Firm initiated