PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-600-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536037144), received between Jan 15, 2025 and Jan 15, 2025 — classified as 1 injury.

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.

• InjuryJan 15, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY DEVICE WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (LICA) CAVERNOUS SEGMENT DURING A PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM WITH A MAXIMUM DIAMETER OF APPROXIMATELY 10MM AND A NECK DIAMETER OF APPROXIMATELY 8MM. THE LANDING ZONES WERE MEASURED AT 3.91MM DISTALLY (JUST PROXIMAL TO THE OPHTHALMIC ARTERY) AND 3.76MM PROXIMALLY (DISTAL PETROUS SEGMENT), WITH NORMAL VESSEL TORTUOSITY. POST-PROCEDURE IMAGING SHOWED GREAT APPOSITION OF THE DEVICE WITH NO ENDOLEAK, AND THE ANEURYSM WAS SUCCESSFULLY ELIMINATED. DURING A SIX-MONTH FOLLOW-UP, IMAGING REVEALED SEVERE FISHMOUTHING OF THE PROXIMAL END OF THE DEVICE, WHICH HAD PREVIOUSLY BEEN WELL APPOSED. THE PHYSICIAN NOTED DIFFICULTY ACCESSING THE IMPLANTED DEVICE WITH ANYTHING MORE THAN A WIRE, DESPITE MULTIPLE TECHNIQUES BEING ATTEMPTED. THE DECISION WAS MADE TO LEAVE THE DEVICE IN PLACE AS THE PATIENT WAS ASYMPTOMATIC, AND THE ANEURYSM REMAINED ELIMINATED. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE STENOSED AREA OF THE DEVICE BUT WAS PLEASED WITH THE OVERALL OUTCOME. THE ACTUAL PROCEDURE DATE WAS (B)(6) 2024.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163621 ↗

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-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-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-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