PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-027-550-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536037021), received between Apr 11, 2024 and Sep 20, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALTERNATIVE PIPELINE DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO CATHETER ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271056 ↗
• MalfunctionMay 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE VANTAGE THAT HAD RESISTANCE DURING DELIVERY IN A PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED RIGHT CAVERNOUS CAROTID SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 15MM AND THE NECK DIAMETER WAS 6MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; PRU LEVEL WAS 62.  IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE DELIVERY SYSTEM WAS IN PLACE WITH THE PHENOM PARKED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). ONCE THE PIPELINE INTRODUCER SHEATH WAS FLUSHED, IT WAS PLACED IN THE HUB OF THE PHENOM. THE PIPELINE WAS ADVANCED ABOUT 10CM AND THEN BECAME STUCK IN THE PROXIMAL END OF THE PHENOM MICROCATHETER AND COULD NOT BE ADVANCED DESPITE APPLYING SOME FORCE TO THE PIPELINE PUSHWIRE. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE; IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE CATHETER. THE ENTIRE SYSTEM WAS REMOVED AND BOTH DEVICES WERE REPLACED. A PIPELINE VANTAGE 600-20 WAS THEN DELIVERED AND DEPLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19365508 ↗
• MalfunctionApr 11, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED3 PIPELINE STENTS HAD SEVERE RESISTANCE IN THE PHENOM27 CATHETER. VANTAGE WAS BEING LOADED INTO PHENOM 27- THERE WAS A LOT OF RESISTANCE. VANTAGE WAS PREMATURELY DEPLOYED IN RHV DUE TO SO MUCH RESISTANCE. THAT DEVICE WAS PULLED OUT AND ANOTHER VANTAGE WAS OPENED. THE 2ND VANTAGE DEVICE STILL HAD A LOT OF RESISTANCE DURING DELIVERY, BUT HE WAS ABLE TO PUSH THROUGH AND GET IT TO THE M1. TIP COIL WAS FOLDED ON ITSELF, BUT DEVICE WAS DEPLOYED WITH NO ISSUES. THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THERE WAS CATHETER KICKBACK. THE PIPELINE DID NOT JUMP DURING DEPLOYMENT. 2 PIPELINES WERE USED TO OVERLAB IN INTERNAL CAROTID ARTERY. THE TIP OF THE CATHETER WAS NOT UNDERSTRESS. THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 5.4MM AND THE NECK DIAMETER WAS 6MM. THE DISTAL LANDING ZONE WAS 4.02MM AND THE PROXIMAL LANDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085663 ↗

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-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-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