PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-400-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536036727), received between May 6, 2024 and Jul 22, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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-1245-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED NO ACTIONS WERE TAKEN TO RESOLVE THE OCCLUSION AND STROKE.

  Patient problems: Failure of Implant; Ischemia Stroke; Obstruction/Occlusion; Stenosis

  MAUDE report 19799813 ↗
• MalfunctionMay 6, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE FAILED TO OPEN IN THE MIDDLE AND DISTAL SECTION. THE PHYSICIAN USED A SHORT SHEATH WITH 7F RIST, PHENOM PLUS AND PHENOM 27, A GUIDEWIRE WAS USED AS WELL. THE PHYSICIAN PREPPED THE VANTAGE PER DFU. TRACKED THE VANTAGE THROUGH THE MICROCATHETER INTO THE PROXIMAL M1. THE PHYSICIAN THEN UNSHEATHED WITH ABOUT 60% PUSH AND 40% UNSHEATH. THE DISTAL END WAS NOT OPENING. HE CONTINUED TO DEPLOY AND THE STENT WAS NOT FULLY OPENING IN THE MIDSECTION. HE RESHEATHED AND SLIGHTLY REPOSITIONED AND THE SAME THING HAPPENED. AT THIS POINT HE WAS NOT CONFIDENT IT WAS NOT GOING TO OPEN, THE STENT ALSO LOOKED TWISTED WITHIN THE MICROCATHETER. HE PULLED OUT THE DEVICE AND WENT IN WITH A 400X16 VANTAGE. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN THE CAPTURE COIL. MORE THAN 50 % HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINEWAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ASSITIONAL STEPS REQUIRED TO OPEN THE PIPELINE. USED THE SHEATH TO RECAPTURED THE PED AND THE MICRO CATHETER IN THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247825 ↗

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-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, 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-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