PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-500-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536036963), received between Feb 26, 2025 and Feb 26, 2025 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathFeb 26, 2025Collapse; Activation, Positioning or Separation Problem; Activation Failure; Collapse; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN DID NOT FEEL THAT THE COMPLICATION WAS RELATED TO THE PIPELINE VANTAGE DEVICE. INSTEAD, THE PHYSICIAN FELT LIKE THE PATIENT WAS ABLE TO LIVE FOR ADDITIONAL TIME BECAUSE OF THE PROCEDURE THAT WAS PERFORMED. THE PATIENT HAD UNDERGONE TREATMENT OF A FUSIFORM DISSECTING GIANT VERTEBRAL ARTERY ANEURYSM THAT WAS VERY CHALLENGING TO TREAT WHICH WAS KNOWN OFF-LABEL USE OF THE PIPELINE VANTAGE. THE IMPLANTATION OF THE PIPELINE WENT EVEN BETTER THAN EXPECTED, WITH ONLY MINOR CHALLENGES. THE PATIENT'S CONDITION IMPROVED OVER TIME POST-OPERATIVELY, HOWEVER, AT 6 MONTH FOLLOW UP THE PATIENT REPORTED SYMPTOMS AND UPON ANGIOGRAPHIC IMAGING, THROMBOSIS AROUND THE IMPLANT AND NARROWING OF THE DEVICES WAS IDENTIFIED. THE PATIENT EXPIRED AROUND 9 MONTHS POST-IMPLANT. THE SOURCE OF THE IN-STENT STENOSIS WAS UNCLEAR BUT THE PHYSICIAN DID NOT ATTRIBUTE IT TO THE PIPELINE AS IT WAS NOTED THE PATIENT HAD OTHER CONDITIONS, AND THE PHYSICIAN CONSIDERED IT MORE LIKELY THAT THE PIPELINE DEVICE CAPTURED SOME THROMBUS, RATHER THAN GENERATING IT. THE PHYSICIAN EMPHASIZED MULTIPLE TIMES THAT THE PATIENT DEATH WAS, ON THEIR PART, NOT CONSIDERED TO BE RELATED T

  Patient problems: Obstruction/Occlusion

  MAUDE report 21472459 ↗

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-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-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-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-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-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