PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-250-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536036215), received between Aug 5, 2024 and Sep 14, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Structural Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Structural Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756323 ↗
• MalfunctionFeb 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION THAT AND PIPELINE STENT USED BALLOON TO OPTIMIZE WALL APPOSITION WHICH WAS ACHIEVED BY THE END OF THE PROCEDURE. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT WALL APPOSITION ACHIEVED WITH BALLOON ASSISTANCE. COMPLETE NECK COVERAGE ACHIEVED. STASIS AT END OF PROCEDURE WAS SIGNIFICANT WITH ANEURYSM OCCLUSION OF RAYMOND & ROY (R & R) CLASS 3 AND R & R CLASS 3 WAS NOT DUE TO A DEVICE DEFICIENCY OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314489 ↗
• InjuryAug 5, 2024Structural Problem; Unintended Movement; Migration; Structural Problem; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TREATED FOR A RUPTURED LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM IN 2023 ¿ IT WAS TREATED WITH AN ATLAS STENT AND COILS. THE PATIENT HAD FAMILY HISTORY OF DEEP VEIN THROMBOSIS AND WAS ON MEDICATION TO TREAT IT; HOWEVER, THEY STOPPED THE MEDICATION A WEEK PRIOR TO THE INTERVENTION. IT WAS NOTED THAT ANEURYSM TREATMENT IN THE ANTERIOR COMMUNICATING ARTERY WAS CONSIDERED OFF LABEL. THE PATIENT WAS MOVED FROM THE ICU AND THEIR STATUS CONTINUED TO DECLINE. THEY DEVELOPED ATRIAL FIBRILLATION (AFIB), PNEUMONIA, UTI AND SUBARACHNOID HEMORRHAGE. THEY ARE UNABLE TO SWALLOW AND SPEAK AND REMAIN IN THE HOSPITAL.

  Patient problems: Aphonia; Aspiration Pneumonitis; Atrial Fibrillation; Bacterial Infection; Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 19907109 ↗

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-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• 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-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-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-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-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