PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-600-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037205), received between Aug 5, 2024 and Jan 15, 2026 — 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.

• MalfunctionJan 15, 2026Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE VANTAGE IMPLANT PROCEDURE WAS PERFORMED ON (B)(6) 2024 AT (B)(6) HOSPITAL. IN (B)(6) 2025, THE PATIENT WENT FOR A FOLLOW UP AND WAS TOLD THAT THE PIPELINE VANTAGE DEVICE MIGRATED DOWN THE CAROTID TO ANOTHER LOCATION. THE ORIGINAL PHYSICIAN LEFT THE PRACTICE SO THEY SAW ANOTHER PHYSICIAN AT (B)(6) HOSPITAL TO FIX THE ISSUE AND RESENT THE ANEURYSM. THE PATIENT WAS SCHEDULED FOR SURGERY IN (B)(6) 2025 HOWEVER THE SURGERY WAS CANCELLED. AT THAT TIME THE PHYSICIAN INFORMED THE PATIENT THAT THE PIPELINE VANTAGE WAS RECALLED AND THEY WERE HAVING ISSUES ORDERING THE PRODUCT. THE PATIENT HAS NO SYMPTOMS OR ADVERSE EFFECTS. IT WAS REPORTED THAT THE ONLY PATIENT GUIDANCE THAT THE CV LIFELINE HAS REGARDING THE RECALL OF THE PIPELINE VANTAGE EMBOLIZATION DEVICE WITH SHIELD TECHNOLOGY IS THE FOLLOWING: FOR PATIENTS WHO HAVE ALREADY BEEN TREATED WITH PIPELINE VANTAGE 027 AND 021 DEVICES: THE TREATING PHYSICIAN SHOULD DETERMINE THE NEED FOR FOLLOW-UP IMAGING OR CHANGES TO MEDICAL MANAGEMENT BASED ON THE PATIENT'S OVERALL HEALTH. THIS INCLUDES WEIGHING THE RISKS OF DUAL ANTIPLATELET THERAPY AGAINST POTENTIAL RISKS FOR BRAID DEFORMATION. RES

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24080387 ↗
• InjuryAug 5, 2024Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PIPELINE DISTAL END WAS OPENED IN A STRAIGHT SEGMENT. THE DEVICES FAILED TO OPEN AT THE GENU OF THE CAVERNOUS SEGMENT. THE FAILURE OCCURRED IN A BEND. THE HEALTHCARE PROVIDER HAS NOT RESCHEDULED THIS PATIENT FOR ANOTHER PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 19907636 ↗

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-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-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