PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536036680), received between Jul 22, 2024 and Dec 8, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Structural Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Structural Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN UNRUPTURED SACCULAR ANEURYSM LOCATED AT THE RIGHT SUPERIOR HYPOPHYSEAL SEGMENT OF THE INTERNAL CAROTID ARTERY UNDERWENT A PROCEDURE INVOLVING THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY. THE DEVICE WAS WELL PLACED WITH GOOD WALL APPOSITION, AND DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THREE-MONTH MRA IMAGING SHOWED A GOOD RESULT. HOWEVER, SIX-MONTH MRA AND CTA IMAGING REVEALED NEAR OCCLUSION OF THE RIGHT INTERNAL CAROTID ARTERY, AND FOLLOW-UP DIGITAL CEREBRAL ANGIOGRAPHY DEMONSTRATED NEAR COMPLETE OCCLUSION OF THE PIPELINE DEVICE FROM ARTERIAL FLOW, POTENTIALLY DUE TO SEVERE IN-STENT STENOSIS OR NEOINTIMAL HYPERPLASIA. THE PIPELINE DEVICE REMAINED WIDE OPEN WITH NO BRAID COLLAPSE OR DEFORMATION. THE PHYSICIAN PLANNED TO CONTINUE DUAL ANTIPLATELET THERAPY AND RE-IMAGE AT ONE YEAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE LANDING ZONE WAS 3MM DISTAL AND 4MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN 8FR PINNACLE SHEATH, NEURON MAX AND APRO 55 IC INTERMEDIATE CATHETERS, PHENOM 27 MICROCAT

  Patient problems: Hyperplasia; Obstruction/Occlusion; Stenosis

  MAUDE report 23749313 ↗
• MalfunctionApr 21, 2025Structural Problem; Activation, Positioning or Separation Problem; Activation Failure; Structural Problem; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS DOING FINE FOLLOWING THE PROCEDURE AND HAD NO SYMPTOMS RELATED TO THE FISHMOUTHING. NO ACTION WAS TAKEN TO RESOLVE THE FISHMOUTHING. IT WAS DECIDED TO LEAVE ALONE AS PATIENT WAS ASYMPTOMATIC. THE CAUSE OF THE FISHMOUTHING WAS NOT DETERMINED. THE PROXIMAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PIPELINE WAS IN A SLIGHT BEND WHEN IT FAILED TO OPEN. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872965 ↗
• MalfunctionOct 29, 2024Unintended Movement; Migration; Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE VANTAGE MIGRATED AFTER DEPLOYMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 4MM. THE LANDING ZONE WAS 3MM DISTAL AND 4MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE VANTAGE DEVICE ON THE DISTAL END MOVED ONCE IT WAS DEPLOYED MAKING IT SO THAT THE DISTAL NECK COVERAGE WAS NOT SUFFICIENT. THEY HAD TO PUT IN A SECOND DEVICE TO COVER THE ANEURYSM NECK COMPLETELY. IT WAS THOUGHT THAT THE MIGRATION WAS POTENTIALLY CAUSED BY PULLING THE PTFE SLEEVES THROUGH THE STENT SINCE THEY WERE UNABLE TO GAIN ACCESS INTO THE STENT WITH MICROCATHETER POST DEPLOYMENT. THE PIPELINE WAS IMPLANTED IN THE INTENDED LOCATION WITH FULL WALL APPOSITION ACHIEVED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE DEVICE POST IMPLANT MIGRATED ON THE DISTAL END SO THAT THE DEVICE WAS NO LONGER COVERING THE NECK OF THE ANEURYSM. THE DEVICE LOOKED PERFECTLY APPOSED PRE-DEPLOYMENT. THE DEVICES WERE PREPARED ACCORDING T

  Patient problems: Failure of Implant

  MAUDE report 20561249 ↗
• InjuryOct 24, 2024Display or Visual Feedback Problem; Component or Accessory Incompatibility; Activation Failure; Display or Visual Feedback Problem; Component or Accessory Incompatibility; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE VANTAGE HAD POOR VISUALIZATION. GIANT RIGHT INTERNAL CAROTID ARTERY (ICA) MEASURING 20 MM. PLANNED FOR PIPELINE VANTAGE ONLY. WAS VERY CHALLENGING GETTING THE WIRE PAST THE ANEURYSM, NECK AND INTO THE M1. AS THE WIRES NATURAL COURSE WAS LEADING IT INTO THE ACTUAL ANEURYSM. AFTER ABOUT 45 MINUTES, THE DOCTOR WAS ABLE TO GET THE WIRE AND THE PHENOM 27 INTO THE M1. THEN BROUGHT THE PIPELINE DEVICE UP, DEPLOYING IT JUST BELOW THE TERMINUS. IT APPEARED THAT THE PIPELINE WAS OPENING UP JUST FINE DISTALLY. IT APPEARED THE PIPELINE WAS BRIDGING THE NECK JUST FINE. THEY DID A CONTRAST INJECTION, AND THERE WAS STAGNATION IN THE ANEURYSM. THE PIPELINE APPEARED TO BE SLOW AND OPENING ON ITS MID PROXIMAL SEGMENT. AFTER SOME WAGGING THAT THE DOCTOR DECIDED TO SHEATH THE REST OF IT AND DEPLOY IT. THE DEVICE WAS EXTREMELY DIFFICULT TO SEE. COULDN'T TELL FROM MANY DIFFERENT ANGLES IF IT WAS FULLY APPEASING THE WALL. THIS BEING SAID, DECIDED TO GO IN WITH A JAY WIRE TO BUMP IT OPEN AGAIN NOT BEING ABLE TO SEE IT AT ALL. THE WIRE WENT DIRECTLY INTO THE ANEURYSM, WHICH TOLD THEM THAT THE VERY LEAST THE PIPELINE WAS NOT COVERING THE NECK ANYMORE. STIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20528668 ↗
• InjuryJul 22, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation Failure; Migration; Activation, Positioning or Separation Problem; Material Deformation; Activation Failure; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAS BEEN RECOVERING IN NEURO ICU. IT WAS STILL UNCLEAR OF WHY THE PROXIMAL SEGMENT DID NOT OPEN.

  Patient problems: Rupture

  MAUDE report 19791376 ↗

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-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-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-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