PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-350-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536036512), received between Aug 27, 2024 and Sep 24, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 30, 2025Class IOpen, Classified

   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

   Z-1246-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Activation, Positioning or Separation Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885204 ↗
• MalfunctionOct 15, 2025Retraction Problem; Unintended Movement; Physical Resistance/Sticking; Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY; HOWEVER, THE DEVICE COULD NOT BE RESHEATHED TO REPOSITION. ADDITIONALLY, IT WAS CLARIFIED THAT THE THIRD ATTEMPT AT TREATMENT WAS SUCCESSFUL WITH THE PHENOM 027 AND PIPELINE SHIELD, NOT WITH VANTAGE AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294161 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN MENTIONED THE EVENT OCCURRED AFTER THE DSA FU AT 1YEAR. THEY DID NOT SPECIFIED A DATE: DSA FU WERE PERFORMED BETWEEN (B)(6) 2024 /(B)(6) 2025. THE MORPHOLOGY OF EACH ANEURYSM WAS UNKNOWN AT THE TIME OF THE REPORT. B679957- VANTAGE ¿ LRRM ¿ PIPELINE VANTAGE OCCLUDED DOCTOR WILL NOT PROCEED WITH ANY INTERVENTIONS. DOCTOR MENTION THAT PATIENT IS STABLE UNDER HIS CONDITION AND DEVELOP GOOD COLLATERALS. (B679957- VANTAGE ¿ LRRM ¿ VANTAGE OCCLUDED WERE IMPLANTED ON (B)(6) 2024). THE OCCLUSION WAS FIRST OBSERVED B679957- VANTAGE ¿ LRRM ¿ PIPE OCCLUDED - (B)(6) 2024.

  Patient problems: Hyperplasia; Obstruction/Occlusion

  MAUDE report 21575522 ↗
• MalfunctionAug 27, 2024Structural Problem; Activation Failure; Structural Problem; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) HAD BOUGHT THE PATIENT BACK FOR A THIRD TIME THINKING THE FISH MOUTHMAY HAVE GOTTEN WORSE AND HE WOULD HAVE TO PUT IN AN ANOTHER PIPELINE. BUT, THE FISHING HAD NOT GOT WORSE. IN FACT IT LOOKED LIKE IT MAY HAVE GOT SLIGHTLY BETTER SO HE LEFT IT. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND.

  Patient problems: Vasoconstriction

  MAUDE report 20080824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck