PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-450-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536036802), received between Jul 16, 2024 and Aug 12, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT UPON FOLLOW UP ON (B)(6) 2025, THE PHYSICIAN NOTICED SEVERE INTIMAL HYPERPLASIA AND FISH MOUTHING OF THE PIPELINE DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) - SUPRACLINOID ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.25MM AND PROXIMAL: 4.3MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT WAS SATISFACTORY POST PIPELINE PLACEMENT. THE STENT WAS COMPRESSED A LITTLE. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT INCLUDING SEVERE INTIMAL HYPERPLASIA AND FISH MOUTHING OF THE DISTAL END OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS KEPT ON DAPT TO RESOLVE THE HYPERPLASIA AND FISH MOUTHING. THE DISTAL END WAS FISH MOUTHED AND THE DEVICE WAS COMPRESSED. THE CAUSE OF THE HYPERPLASIA AND FISH MOUTHING WAS NOT DETERMINED. ANCILLARY DEVICES INCLUDE A SHEATH, PHENOM PLUS GUIDE CATHE

  Patient problems: Hyperplasia

  MAUDE report 22787747 ↗
• MalfunctionApr 1, 2025Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY DEVICE EXHIBITED DISTAL END FISHMOUTHING AND HYPERPLASIA DURING FOLLOW UP. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE ANEURYSM WAS LOCATED AT THE HYPOTHESEAL REGION, WAS UNRUPTURED, AND HAD A SACCULAR MORPHOLOGY WITH A MAXIMUM DIAMETER OF 2.5 MILLIMETERS AND A NECK DIAMETER OF 2 MILLIMETERS. THE LANDING ZONE ARTERY SIZES WERE 3.5 MILLIMETERS DISTALLY AND 4.5 MILLIMETERS PROXIMALLY, WITH MODERATE VESSEL TORTUOSITY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THOUGH THE PLATELET REACTIVITY UNIT LEVEL WAS UNKNOWN. ANCILLARY DEVICES: ARMADILLO SHEATH, PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS ASYMPTOMATIC. THE PHYSICIAN LEFT THE DEVICE ALONE AND WILL FOLLOW UP IN 6 MONTHS.

  Patient problems: Hyperplasia

  MAUDE report 21746672 ↗
• MalfunctionMar 11, 2025Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS NOT EXPERIENCING ANY SYMPTOMS. NO FURTHER ACTIONS WERE TAKEN. PATIENT WILL BE OBSERVED. THE PIPELINE WAS NOT PLACED IN A BEND WHEN IT FAILED TO OPEN.

  Patient problems: Hyperplasia; Stenosis

  MAUDE report 21580133 ↗
• InjuryFeb 5, 2025Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING SYMPTOMS. NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE ADVERSE EVENTS. THE CAUSE OF THE FORESHORTENING WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND.

  Patient problems: Headache; Ischemia Stroke; Numbness; Visual Disturbances

  MAUDE report 21314494 ↗
• MalfunctionJan 8, 2025Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY, THE DEVICE BECAME STUCK DURING RESHEATHING IN THE DISTAL SECTION OF THE PHENOM 27 MICROCATHETER. THE CATHETER, SPECIFICALLY THE DISTAL SECTION, EXPERIENCED RESISTANCE AND WAS FOUND TO BE DAMAGED, DESCRIBED AS FLATTENED AND KINKED. ADDITIONALLY, RESISTANCE WAS ENCOUNTERED IN THE MIDDLE SECTION OF THE PHENOM PLUS CATHETER USED IN THE PROCEDURE. THE PROCEDURE INVOLVED TREATING AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY, WITH SEVERE VESSEL TORTUOSITY NOTED. THE MAX DIAMETER AND NECK DIAMETER WERE 5MM. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.5MM PROXIMAL. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY WITH A DIAMETER OF 5MM OR ABOVE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE APPEARED SATISFACTORY. THE PHYSICIAN ATTEMPTED TO RELEASE THE LOAD IN THE SYSTEM TO RESOLVE THE ISSUE, BUT IT WAS UNSUCCESSFUL. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. THE TRI-AXIAL SYSTEM WAS INITIALLY POSITIONED CORRECTLY, BUT AS THE DEVICE WAS MANEUVERED, THE VANTAGE DEVICE BEGAN TO RIBBON OR FLATTEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103723 ↗
• MalfunctionJul 16, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) FEELS IT WAS HIS ERROR IN GETTING THE DEVICE TO TRY TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19751672 ↗

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-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-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-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