PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-550-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536037007), received between Oct 2, 2024 and Dec 10, 2024 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC INTERNAL CAROTID ARTERY WITH A MAXIMUM DIAMETER OF 5.1 MILLIMETERS AND A NECK DIAMETER OF 4.0 MILLIMETERS WAS BEING TREATED. THE PATIENT HAD SEVERE VESSEL TORTUOSITY. THE PIPELINE EMBOLIZATION DEVICE (PED2-475-12) FAILED TO OPEN IN THE DISTAL SECTION AND BECAME STUCK IN THE PHENOM 27 MICROCATHETER UPON REMOVAL. THEY HAD ATTEMPTED TO REPOSITION THE PIPELINE WITH THE MICROCATHETER IN AN ATTEMPT TO OPEN IT. MORE THAN 50% OF THIS DEVICE WAS DEPLOYED BEFORE THE FAILURE, AND IT WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES BEFORE BEING REMOVED FROM THE PATIENT. THE DEVICE HAD NOT BEEN POSITIONED IN A BEND. ADDITIONALLY, A PIPELINE VANTAGE WITH SHIELD TECHNOLOGY (PED3-027-550-16) FAILED TO OPEN IN THE MIDDLE SECTION. THE DISTAL SEGMENT HAD BEEN POSITIONED IN A BEND. MORE THAN 50% OF THIS DEVICE WAS DEPLOYED, AND IT WAS RESHEATHED MORE THAN TWO TIMES BEFORE REMOVAL. ANOTHER PIPELINE VANTAGE 5X14 WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893491 ↗
• InjuryOct 2, 2024Collapse; Migration; Collapse; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED AFTER IMPLANTATION OF THE PIPELINE THREE RUNS OF CONTRAST WERE DONE TO CONFIRM PIPELINE LOCATION AND APPOSITION. ALL OF THESE SHOWED GOOD APPOSITION AND PROPER LOCATION OF THE DEVICE. 10 MINUTES AFTER THE PROCEDURE, THE PATIENT AWOKE AND EXPERIENCED INABILITY TO MOVE RIGHT SIDE EXTREMITIES. CTA SHOWED DISPLACEMENT AND MIGRATION OF THE PIPELINE VANTAGE INTO THE RIGHT M1 ICA SEGMENT. IMAGING REVEALED THROMBUS FORMATION IN THE LUMEN OF THE PIPELINE DEVICE. A BOLUS OF INTEGRILIN AND A SUBSEQUENT INFUSION OF THIS MEDICATION WAS INITIATED. A REPEAT PHYSICAL EXAM REVEALED AN IMPROVEMENT OF THE LEFT HEMIPARESIS. A REPEAT ANGIOGRAM SHOWED A DISTAL MIGRATION OF THE PIPELINE TOWARDS THE DISTAL CAVERNOUS SEGMENT, BOTH PORTIONS OF THE DEVICE, DISTAL AND PROXIMAL MIGRATED. THE PROXIMAL END OF THE DEVICE COVERAGE OF THE NECK OF THE ANEURYSM WAS MINIMAL AND AROUND 1-3MM. A SMALL RESIDUAL THROMBUS WAS OBSERVED WITHIN THE DEVICE AND THERE WAS GOOD FLOW IN THE CAROTID. FOR THESE REASONS, IT WAS DECIDED THAT IT WAS BEST TO LEAVE THE DEVICE ALONE. IT WAS THOUGHT THAT ANY SMALL THROMBUS AROUND THE DEVICE WOULD LYSE DUE TO THE PATIENT'S ANTIPLATELET REGIMEN. AT AR

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Muscle Weakness/Atrophy; Paresis; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 20352069 ↗

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-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-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-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