PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-450-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536036826), received between Nov 22, 2024 and Nov 22, 2024 — 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.

• InjuryNov 22, 2024Collapse; Structural Problem; Activation, Positioning or Separation Problem; Activation Failure; Collapse; Structural Problem; Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED THAT A PIPELINE VANTAGE WITH SHIELD TECHNOLOGY WAS INVOLVED IN A NEUROVASCULAR FLOW DIVERSION PROCEDURE FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. TWO DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED STROKE-LIKE SYMPTOMS. IMAGING REVEALED THAT THE PROXIMAL END OF THE STENT HAD COLLAPSED AND FORESHORTENED, OBSTRUCTING NORMAL BLOOD FLOW, WHICH CAUSED A STROKE. THERE WAS A FAILURE TO OPEN IN THE PROXIMAL AND MIDDLE SECTIONS OF THE PIPELINE, WHICH WAS POSITIONED IN A BEND IN THE MIDDLE SECTION. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES, AND BALLOON ANGIOPLASTY WAS REQUIRED TO OPEN IT. THE VESSEL TORTUOSITY WAS NOTED AS SEVERE. THE ANGIOGRAPHIC RESULT IMMEDIATELY POST-PROCEDURE APPEARED FINE. THE PIPELINE WAS NOT REMOVED FROM THE PATIENT, AND FULL WALL APPOSITION WAS ACHIEVED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER AND A NON-MEDTRONIC SHEATH.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion

  MAUDE report 20762568 ↗

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-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-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