PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-500-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536036901), received between May 21, 2024 and Jul 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  2025-JUN-26 (B)(4): MEDTRONIC RECEIVED A REPORT THAT A PATIENT FOLLOW UP FROM (B)(6) 2024 SHOWED THE PIPELINE VANTAGE HAD SIGNIFICANT STENOSIS ON THE DISTAL END OF THE DEVICE CAUSING THE DISTAL END TO FISHMOUTH. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.8MM AND PROXIMAL 4.9MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL STASIS IN THE DOME OF THE ANEURYSM.

  Patient problems: Stenosis

  MAUDE report 22372881 ↗
• MalfunctionOct 25, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE VANTAGE FAILED TO OPEN. WOULD NOT OPEN IN THE PROXIMAL GENU. THE DEVICE WAS PULLED OUT WHEN IT DID NOT OPEN IN THE PROXIMAL GENU. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20536218 ↗
• MalfunctionMay 21, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE WOULD NOT OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A 5X5 MM RIGHT SUPERIOR HYPOPHOSEAL ANEURYSM. AFTER PLACING THE 7FR RIST, PHENOM PLUS, AND PHENOM 27, THE HEALTHCARE PROVIDER DECIDED THAT A 5X16 PIPELINE VANTAGE WOULD BE THE BEST SIZE TO TREAT. AFTER PREPARING THE PED3, THE HEALTHCARE PROVIDER ADVANCED THE STENT WITHOUT ISSUE INTO POSITION. THEY TRIED TO DEPLOY THE STENT BUT THE DISTAL END WOULD NOT OPEN. THE PIPELINE WAS RECOVERED AND REDEPLOYED SEVERAL TIMES BUT WOULD NOT OPEN DISTALLY. THE HEALTHCARE PROVIDER THEN DECIDED TO PULL THE STENT OUT AND TAKE A 5X14 INSTEAD. AFTER REMOVING THE STENT THEY NOTICED THE DISTAL END WAS "CONED DOWN." THE 5X14 WAS PLACED WITHOUT ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.  ANCILLARY DEVICES: GUIDE CATHETER 7FR RIST, MICROCATHETER PHENOM 27, AND PHENOM PLUS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362280 ↗

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-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