PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284381), received between May 29, 2025 and Dec 4, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

12 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.

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.

• MalfunctionDec 4, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CAVERNOUS SINUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 12.52 MM AND A 9.27 MM NECK DIAMETER LOCATED AT THE C4 SEGMENT OF THE INTRACRANIAL INTERNAL CAROTID ARTERY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.06MM DISTALLY AND 3.93MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 9.86MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS WELL. IT WAS REPORTED THAT A PED2-400-30 WAS SELECTED FOR IMPLANTATION. AFTER ADEQUATE HYDRATION, THE PED2-400-30 WAS DELIVERED TO THE STENT CATHETER. HOWEVER, THE DENSE MESH STENT DID NOT OPEN WELL AT THE MIDSECTION BEND. THE OPERATOR MADE MULTIPLE ATTEMPTS, INCLUDING REPEATED PUSHING, PULLING, REPOSITIONING, AND REDEPLOYING, BUT THE STENT STILL DID NOT OPEN PROPERLY. CONSIDERING THE POSSIBILITY OF INTIMAL INJURY DUE TO REPEATED MANIPULATION AND THE COMPLEXITY OF THE PROCEDURE, THE STENT AND MICROCATHETER WERE WITHDRAWN. AFTER DISCUSSING WITH THE PATIENT'S FAMILY, THE SURGERY WAS CANCELED. THE PIPELINE WAS USED FOR AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715701 ↗
• MalfunctionNov 3, 2025Material Deformation; Material Twisted/Bent; Activation Failure; Material Deformation; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING STENT DEPLOYMENT, THE STENT TWISTED AND OPENED ABNORMALLY. THE MIDDLE SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THERE WERE NO DEVICE ISSUES WITH THE PHENOM 27. THE CAUSE OF THE EVENT WAS NOT DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN PUSHED THE INTERMEDIATE CATHETER TO GO UPPER IN ANOTHER ATTEMPT TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451213 ↗
• DeathMay 29, 2025Positioning Failure; Retraction Problem; Structural Problem; Activation, Positioning or Separation Problem; Physical Resistance/Sticking; Positioning Failure; Retraction Problem; Structural Problem; Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PROBLEM OCCURRED THAT DAY AND THE PATIENT DIED. THE PATIENT PASSED AWAY AT (B)(6), DOCTOR INFORMED THAT THE PATIENT DIED IN THE HOSPITAL. NO AUTOPSY RECORDS WILL BE AVAILABLE. THE PATIENT'S DEATH MAY BE RELATED TO THE PIPELINE SHIELD, AND IT MAY ALSO BE RELATED TO THE OPERATOR'S OPERATION. THERE WAS INTRACRANIAL ANEURYSM LEADING UP TO THE PATIENT'S DEATH. THE CAUSE OF THE RESISTANCE DURING RETRIEVAL MAY BE VASCULAR TORTUOSITY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Intracranial Hemorrhage; Rupture

  MAUDE report 22104668 ↗

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-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-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-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