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Pipeline Fa-71450-35

by Micro Therapeutics, Inc. 3 variants

Pipeline Fa-71450-35 is a Class III device made by Micro Therapeutics, Inc., approved under FDA PMA P100018 on 6 Apr 2011 and listed in FDA GUDID since 3 Apr 2015 (UDI-DI 00847536009646), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

PMA P100018

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847536009646 UDI-DI Date3 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP100018 Date6 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P100018 decided 6 Apr 2011 Active
  • FDA GUDID UDI-DI 00847536009646 listed 3 Apr 2015 Listed

Recalls

12 recalls · 4 ongoing · FDA

  • 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.

Timeline

14 dated events

  1. Recall initiated FDA recalls Z-0120-2016
  2. Recall initiated FDA recalls Z-0309-2017
  3. Recall initiated FDA recalls Z-0308-2017
  4. Recall initiated FDA recalls Z-0307-2017
  5. Recall initiated FDA recalls Z-0310-2017
  6. Recall initiated FDA recalls Z-1527-2020
  7. Recall initiated FDA recalls Z-2403-2021
  8. Recall initiated FDA recalls Z-2402-2021
  9. Recall initiated FDA recalls Z-1245-2025
  10. Recall initiated FDA recalls Z-1246-2025

4 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Pipeline
Generic name
Bare-metal intracranial vascular stent
Model / reference
FA-71450-35
Primary DI / UDI-DI
00847536009646
PMA number
FDA product code
OUT
GMDN term
Bare-metal intracranial vascular stent
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Bare-metal intracranial vascular stent

Cleared under the same submission (P100018)

and 8 more cleared under P100018

Similar devices

Other devices filed under FDA product code OUT (Intracranial aneurysm flow diverter).

Other devices from Micro Therapeutics, Inc.

See all devices from Micro Therapeutics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)