PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-250-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536036246), received between Nov 1, 2024 and Jun 2, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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-1246-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WERE NO ALLEGED PRODUCT ISSUES DURING THE CASE, BUT THE PATIENT PRESENTED IN THE EMERGENCY ROOM WITH A STROKE. THEY NOTED THE ANEURYSM AND THE PIPELINE VANTAGE HAD THROMBOSED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL) AS THE DEVICE WAS USED IN THE RIGHT PCA. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT HAD TO GO TO REHAB DUE TO THE STROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED RIGHT PCA ANEURYSM WITH A MAX DIAMETER OF 9 MM. THE LANDING ZONE WAS 1.4 MM DISTALLY AND 1.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 44. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GREAT.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 25365559 ↗
• MalfunctionApr 7, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS UNABLE TO BE DETERMINED WHETHER THERE WAS A DEVICE ISSUE WITH THE PHENOM MICROCATHETERS USED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE OF THE PIPELINE (PED3 021 250 16) TO OPEN WERE IDENTIFIED. NEITHER THE DISTAL NOR THE MIDDLE SEGMENT OF THE PIPELINE COULD BE DEPLOYED PROPERLY. THE PIPELINE DEVICES WERE NOT PLACED IN A VESSEL BEND AT THE TIME OF THE DEPLOYMENT FAILURE. ADDITIONAL ATTEMPTS WERE MADE TO OPEN THE DEVICE, INCLUDING THREE RETRIEVAL ATTEMPTS AND MANEUVERS SUCH AS PUSHING AND SWAYING THE MICROCATHETER; HOWEVER, DESPITE THESE EFFORTS, THE DEVICE COULD NOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800243 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 2.5MM DISTALLY AND 2.5MM PROXIMALLY. IT WAS UNKNOWN IF THE DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE VANTAGE DEVICE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO COMPLICATIONS UNTIL YESTERDAY WHEN PHYSICIAN INFORMED THAT PATIENT HAD STROKE FOLLOWING PROCEDURE. HE IS RECOVERING. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL), IT WAS USED IN ANTERIOR CEREBRAL ARTERY (ACA). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion; Stenosis

  MAUDE report 22175702 ↗
• InjuryNov 1, 2024Malposition of Device; Unintended Movement; Migration; Physical Resistance/Sticking; Malposition of Device; Unintended Movement; Migration; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR THOUGHT THE ORIGINAL VANTAGE MAY HAVE MIGRATED BECAUSE THE DISTAL BRAID OF THE PIPELINE LANDED TOO CLOSE TO THE NECK OF THE ANEURYSM AND DIDN¿T HAVE ENOUGH PURCHASE TO STAY IN POSITION. THERE WAS NO DAMAGE TO THE PIPELINE OR PUSHER WIRE USED FOR THE ORIGINAL CASE DONE ON (B)(6)2024.

  Patient problems: Failure of Implant

  MAUDE report 20585149 ↗

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-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-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-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