PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-550-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037045), received between Aug 20, 2024 and Aug 21, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE PETROS SEGMENT. THE MAX DIAMETER WAS 10+MM, AND THE NECK DIAMETER WAS 5+MM. THE LANDING ZONE WAS 5.27MM DISTAL AND 5.70MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE BOTH DEVICES THEY BOTH WOULD NOT OPEN FULLY DISTALLY AND IN THE MIDDLE SEGMENTS OF DEVICE AROUND A CURVE. THEY TRIED ALL CLINICAL TECHNIQUES IN TRYING TO TO OPEN WITH NO SUCCESS. THEY STARTED WITH A 6X40MM VANTAGE FIRST WITH NO LUCK GETTING TO OPEN. THE DEVICE WAS REMOVED AND THEY THEN TRIED A 5.5X30MM VANTAGE, BUT STILL HAD THE SAME ISSUE. THE DOCTOR REMOVED THE SECOND DEVICE AS WELL AND CANCELED THE CASE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A STRYKER CAT 5 GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO GUIDEWIRE.

  Patient problems: Failure of Implant

  MAUDE report 20016261 ↗
• MalfunctionAug 20, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM 27 WAS DIRECTED OVER WIRE WELL PAST THE ANEURYSM TO THE DISTAL LANDING ZONE. DISTAL END WAS UNSHEATHED AND OPENED. DEVICE LOOKED RIBBONED/FLAT AROUND POSTERIOR GENU. DEVICE WAS MANIPULATED INCLUDING RECAPTURE, WAG, LOADING SYSTEM BUT WOULD NOT OPEN. DEVICE WAS RECAPTURED IN THE MICROCATHETER AND REMOVED FROM THE PATIENT. THE DEVICE FAILED TO OPEN IN THE MIDDLE SECTION OF THE PIPELINE. THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% OF IT HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT WAS RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." THERE WERE NO ADDITIONAL STEPS TAKEN, IT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE DEVICE WAS USED FOR AN INDICATION THAT IS APPROVED AND THE PIPELINE AND ANY ACCESSORY DEVICES PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS REPORTED. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ANOTHER PIPELINE SHIELD WAS PLACED INSTEAD OF VANTAGE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 6MM AND A NECK DIAMETER OF 4MM. THE LANDING ZONE WAS 7MM DISTAL AND 5MM PROXIMAL. VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDED A PHENOM27 150CM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007063 ↗

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-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-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-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-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