PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-250-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536036239), received between Jun 3, 2025 and Sep 29, 2026 — classified as 2 deaths, 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-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.

• InjurySep 29, 2026Off-Label Use; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Ruptured Aneurysm

  MAUDE report 50935752 ↗
• MalfunctionApr 7, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF TWO PIPELINE VANTAGE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE BASILAR ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 1.3MM DISTAL AND 1.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NONE. THERE ARE IMAGES AVAILABLE FOR REVIEW. IT WAS REPORTED THAT DURING FLOW-DIVERTING STENT IMPLANTATION FOR AN ANEURYSM, THE ANEURYSM WAS A FUSIFORM ANEURYSM LOCATED IN THE P2 SEGMENT. THE INTERMEDIATE CATHETER WAS IN PLACE, AND THE MICROCATHETER WAS POSITIONED APPROPRIATELY. A 250-14 STENT WAS SELECTED. AFTER DELIVERING THE STENT TO THE TARGET POSITION, THE TIP END OF THE STENT FAILED TO OPEN PROPERLY. DESPITE CONTINUED DEPLOYMENT, THE STENT REMAINED ROD-SHAPED. IT WAS RETRIEVED AND REDEPLOYED THREE TIMES IN AN ATTEMPT TO ACHIEVE OPENING, BUT IT STILL FAILED TO OPEN. THE MICROCATHETER AND STENT WERE REPLACED AND THE REPLACEMENTS WERE ADVANCED TO THE TARGET PO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800213 ↗
• DeathOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS IMPLANTED SUCCESSFULLY BUT THAT THE PATIENT EXPERIENCED HEMORRHAGE AND NEEDED SURGICAL INTERVENTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT ANTERIOR CEREBRAL ARTERY (A1-A2) WITH A MAX DIAMETER OF 2.2 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE WAS 2.15 MM DISTALLY AND 2.26 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE ANGIO SUITE FOR A PIPELINE EMBOLIZATION OF AN ANTERIOR CEREBRAL ARTERY ANEURYSM. THE SURGEON ADVANCED THE PHENOM27 AND THE NON-MEDTRONIC GUIDEWIRE (DRIVEWIRE) INTO THE VASCULATURE AND THEN REMOVED IT AND OPTED FOR A PIPELINE VANTAGE. THE PHENOM21 AND ANOTHER NON-MEDTRONIC GUIDEWIRE WERE THEN ADVANCED THROUGH THE VASCULATURE DISTAL TO THE TARGET LANDING ZONE, AS INSTRUCTED IN THE IFU. A PIPELINE WAS SELECTED AS THE APPROPRIATE SIZE, IT WAS PREPPED IN THE NORMAL FASHION AND INTRODUCED TO THE TARGET VASCULATURE. THE DEPLOYMENT WAS SMOOTH AND UNEVENTFUL. THE PATIENT WAS AWAKENED AFTER THE PROCEDURE AND TRANSPORTED TO THE RECOVERY AREA. AT THIS TIME, THE SURGICAL TEAM WAS ALERTED THAT THE PA

  Patient problems: Hemorrhagic Stroke; Muscle Weakness/Atrophy; Speech Disorder

  MAUDE report 23350447 ↗
• DeathJun 3, 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 AN AMORPHOUS, UNRUPTURED LEFT VERTEBRAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A 3.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 1.7MM DISTALLY AND 2MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE ACCESS PAST THE ANEURYSM WAS NOT ABLE TO BE ACHIEVED FROM THE LEFT SIDE. ATTEMPTED COIL PLACEMENT BUT COILS WOULD NOT STAY IN THE ANEURYSM. THE PHYSICIAN DECIDED TO CROSS FROM THE RIGHT VERTEBRAL ARTERY AND DEPLOY A PIPELINE VANTAGE. THE DEVICE WAS DEPLOYED WITHOUT INCIDENT. AFTER THE PROCEDURE WAS CONCLUDED, THE PATIENT VOMITED AND BECAME UNRESPONSIVE IN RECOVERY. A CT SCAN WAS CONDUCTED, AND A HEMORRHAGE WAS SEEN. EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED, AND THE PATIENT BECAME RESPONSIVE. APPROX 30 MINS LATER, THE PATIENT BECAME UNRESPONSIVE AGAIN AND THE PUPILS WERE FIXED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED GOOD APPOSITION, AND NO COMPLICATIONS NOTED. THE PIPELINE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WER

  Patient problems: Hemorrhagic Stroke; Loss of consciousness; Visual Disturbances; Vomiting

  MAUDE report 22132599 ↗

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-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-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-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