Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology

• 2 recalls, same reason

  • Ongoing Z-1245-2025 FDA Class I ·initiated 30 Jan 2025
  • Ongoing Z-1246-2025 FDA Class I ·initiated 30 Jan 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 procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

• 2 recalls, same reason

  • Ongoing Z-2403-2021 FDA Class I ·initiated 13 Jul 2021
  • Ongoing Z-2402-2021 FDA Class I ·initiated 13 Jul 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.

• • Terminated Z-1527-2020 FDA Class I ·initiated 14 Feb 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 system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.

• 4 recalls, same reason

  • Terminated Z-0309-2017 FDA Class I ·initiated 5 Oct 2016 ·on shared PMA P100018
  • Terminated Z-0308-2017 FDA Class I ·initiated 5 Oct 2016 ·on shared PMA P100018
  • Terminated Z-0307-2017 FDA Class I ·initiated 5 Oct 2016
  • Terminated Z-0310-2017 FDA Class I ·initiated 5 Oct 2016 ·on shared PMA P100018

  Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.

• • Terminated Z-0120-2016 FDA Class II ·initiated 4 Sep 2015

  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.

• • Terminated Z-1453-2014 FDA Class I ·initiated 1 Apr 2014 ·on shared PMA P100018

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

• • Terminated Z-2045-2013 FDA Class II ·initiated 19 Jul 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 whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Pipeline Embolization Device

Generic Name

Intracranial aneurysm flow diverter

PMA Number

P100018 ↗

FDA Product Code

OUT

Device Class

Class III

Advisory Committee

Neurology

FDA Decision

APPR Approved

• Cadence

  Class I

  CE/MDR

• 1 mL syringe

  Class I

  CE/MDR

• Onyx SCIFA

  Class I

  CE/MDR

• Riptide Aspiration System

  Class II

  FDA 510(k) K201689 Active Cleared 21 Jul 2020

• Solitaire 2 Revascularization Device

  Class II

  FDA 510(k) K162539 Active Cleared 10 Nov 2016

• Axium Detachable Coil; Axium Prime Detachable Coil

  Class II

  FDA 510(k) K233420 Active Cleared 7 Nov 2023

See all devices from Micro Therapeutics, Inc. d/b/a ev3 Neurovascular →

• What is the Pipeline Flex Embolization Device used for in clinical practice?

  The Pipeline Flex Embolization Device is designed to treat large or giant wide-necked intracranial aneurysms in adults aged 22 and above. It works by diverting blood flow away from the aneurysm sac in the internal carotid artery, reducing pressure and promoting natural healing. This is specifically for aneurysms located between the petrous and superior hypophyseal segments.

• Is the Pipeline Flex Embolization Device intended for reuse, or is it single-use?

  The Pipeline Flex Embolization Device is explicitly supplied as a single-use, endovascular implant. It requires sterile handling and cannot be reused after deployment, as is standard for most intracranial implants.

• What regulatory pathway does the Pipeline Flex Embolization Device follow, and how can I verify its approval?

  The device follows the FDA Premarket Approval (PMA) pathway, with the PMA number **P100018**. It was approved for its intended use in intracranial aneurysm treatment after undergoing a rigorous review process, including an expedited review. The approval notice was published in the Federal Register on **2011-04-20**.

• Are there different sizes or models available for the Pipeline Flex Embolization Device?

  Yes, the Pipeline Flex Embolization Device comes in multiple sizes, as indicated by the **FEI numbers** (e.g., 3010079067, 3007628272, etc.) listed in the regulatory records. These variations allow for customization based on anatomical requirements during deployment in the internal carotid artery.

• How should the Pipeline Flex Embolization Device be stored before use?

  Since it is a sterile, single-use device, storage conditions must maintain sterility until deployment. While specific storage instructions are not detailed here, typical best practices for endovascular implants—such as keeping it in a sealed, sterile packaging at room temperature away from direct sunlight—should be followed. Always refer to the manufacturer’s provided instructions for precise storage guidelines.