# P100018: Pipeline Embolization Device

- Pathway: PMA
- Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decided: Apr 6, 2011 after 323 days
- Product code: OUT (Intracranial Aneurysm Flow Diverter)
- Device class: 3
- Recalls of this device: 12 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jan 30, 2025 · Class I · Z-1245-2025: Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during proce
- Jan 30, 2025 · Class I · Z-1246-2025: Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during proce
- Jul 13, 2021 · Class I · Z-2402-2021: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
- Jul 13, 2021 · Class I · Z-2403-2021: Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
- Feb 14, 2020 · Class I · Z-1527-2020: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery 
- Oct 5, 2016 · Class I · Z-0307-2017: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
- Oct 5, 2016 · Class I · Z-0308-2017: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
- Oct 5, 2016 · Class I · Z-0309-2017: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
- Oct 5, 2016 · Class I · Z-0310-2017: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
- Sep 4, 2015 · Class II · Z-0120-2016: 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.
- Apr 1, 2014 · Class I · Z-1453-2014: Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delivery wire.
- Jul 19, 2013 · Class II · Z-2045-2013: Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in 

Source page: https://510kreport.com/device/P100018
Methodology: https://510kreport.com/methodology