PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-300-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536036352), received between May 19, 2025 and May 19, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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-1246-2025 · 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.

• InjuryMay 19, 2025Collapse; Activation, Positioning or Separation Problem; Collapse; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN PLACED A VANTAGE ON (B)(6) 2025 IN THE A1-A2 OF THE PATIENT'S RIGHT SIDE TO COVER A PREVIOUSLY CLIPPED ACOM THAT HAD RECURRED. THE PATIENT RETURNED ON (B)(6) 2025 WITH A RIGHT SIDE STROKE IN THE A2 SEGMENT. ANGIO CONFIRMED THE DISTAL PORTION OF THE DEVICE HAD SHUT DOWN. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY OPEN THE A2 SEGMENT WITH ASPIRATION AND AN ATLAS STENT. THE PHYSICIAN CONFIRMED THAT THE PATIENT DID MISS THEIR DOSE OF DAPT FOLLOWING DISCHARGE FROM THE HOSPITAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ACOM ANEURYSM WITH A MAX DIAMETER OF 1MM AND A 1MM NECK DIAMETER. LANDING ZONE: DISTAL: 2.5MM AND PROXIMAL: 2.2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY OPEN THE A2 SEGMENT WITH AN ATLAS STENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). IT WAS USED IN THE A1-A2 SEGMENT ON THE PATIENT'S LEFT SID E. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). TH

  Patient problems: Ischemia Stroke; Speech Disorder

  MAUDE report 22046858 ↗

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-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-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-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-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