Pipeline TM Flex Embolization Device with Shield Technology TM PED2-400-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000449209), received between Dec 15, 2025 and Mar 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Unintended Ejection; Retraction Problem; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A MICRO ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY WAS TREATED WITH A NEUROENDOVASCULAR FLOW DIVERTER STENT IMPLANTATION. INITIAL ACCESS WAS ESTABLISHED WITHOUT ISSUE, AND THE PHENOM 27 CATHETER WAS SUCCESSFULLY ADVANCED TO THE MIDDLE CEREBRAL ARTERY. AFTER THE STENT WAS FULLY HYDRATED WITH HIGH PRESSURE NORMAL SALINE, DELIVERY WAS INITIATED AND INITIALLY PROCEEDED SMOOTHLY; HOWEVER, COMPARED WITH PRIOR EXPERIENCE, SLIGHTLY INCREASED RESISTANCE WAS NOTED DURING STENT DELIVERY. THE DISTAL END OF THE STENT WAS INITIALLY DEPLOYED IN THE MIDDLE CEREBRAL ARTERY, WITH APPROXIMATELY 8 MM EXPOSED AND OPENING APPROPRIATELY. THE SYSTEM WAS THEN PULLED BACK AS A UNIT FOR POSITIONING; HOWEVER, DURING REPOSITIONING, THE STENT MIGRATED AS A WHOLE. WHEN ATTEMPTING TO RECAPTURE THE STENT, UNUSUALLY HIGH RESISTANCE WAS ENCOUNTERED. AFTER FORCEFUL BUT SUCCESSFUL RECAPTURE, A SECOND DEPLOYMENT WAS ATTEMPTED; HOWEVER, THE STENT COULD NOT BE ADVANCED OUT OF THE PHENOM 27 DELIVERY CATHETER IN THE DISTAL SECTION. ABNORMALLY HIGH RESISTANCE WAS FELT WITHIN THE CATHETER DURING MULTIPLE CAREFUL ATTEMPTS, AND SMOOTH OPERATION WAS NOT POSSIBLE. A POTENTIAL ABNORMALITY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713995 ↗
• MalfunctionMar 23, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE WAS 3.56 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MILD. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.2MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT BY FOLLOWING STANDARD PROCEDURE, THE OPERATOR ADVANCED THE PHENOM27 CATHETER TO THE DISTAL M1 SEGMENT. A PED2-4-20 STENT WAS THEN DELIVERED. AFTER THE STENT WAS POSITIONED, THE MICROCATHETER WAS WITHDRAWN APPROXIMATELY 15 MM, AT WHICH POINT THE DISTAL END OF THE STENT FAILED TO OPEN PROPERLY. THE OPERATOR SUBSEQUENTLY FOLLOWED THE STANDARD PROCEDURAL STEPS TO RESHEATH AND ATTEMPT REDEPLOYMENT. ALTHOUGH THE DISTAL PORTION OF THE STENT PARTIALLY OPENED, IT COULD NOT BE FULLY DEPLOYED. IT WAS SUSPECTED THAT THE DISTAL END OF THE STENT MIGHT HAVE BEEN DAMAGED. THE STENT WAS THEN REMOVED FROM THE BODY, AND INSPECTION CONFIRMED DAMAGE TO THE DISTAL END, PREVENTING FULL EXPANSION. THE DEVICE WAS REPLACED WITH A PED2-3.75-25 STENT, WHICH WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663115 ↗
• MalfunctionDec 29, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE FAILURE TO OPEN COULD BE DETERMINED. THE PIPELINE HAVE NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908581 ↗
• MalfunctionDec 15, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE TREATMENT OF A RIGHT C6 SEGMENT ANEURYSM, AFTER OPENING THE NAVIEN 072, PHENOM 27, AND AVIGO, THE PHENOM 27 WAS ADVANCED TO THE LESION SITE. THE DENSE MESH FLOW-DIVERTING STENT PED2-400-20, LOT D052881 WAS FULLY FLUSHED BEFORE INTRODUCED INTO THE PHENOM 27. IT WAS THEN ADVANCED INTO THE PHENOM 27 AND PUSHED TO THE TARGET LESION, AND DEPLOYMENT OF THE STENT WAS INITIATED. DURING DEPLOYMENT, IT WAS FOUND THAT THE TIP COULD NOT BE OPENED. THE STENT WAS WITHDRAWN INTO THE PHENOM 27, AND AN ATTEMPT WAS MADE TO RE-DEPLOY BY PUSHING THE PUSHER ROD, BUT IT STILL FAILED TO OPEN. MULTIPLE ATTEMPTS OF PUSHING, PULLING, RETRIEVING, AND REDEPLOYING WERE UNSUCCESSFUL. SUBSEQUENTLY, BOTH THE PHENOM 27 AND THE DENSE MESH FLOW-DIVERTING STENT WERE REMOVED FROM THE BODY. WHEN ATTEMPTING TO PUSH THE DENSE MESH FLOW-DIVERTING STENT OUT OF THE PHENOM 27 OUTSIDE THE BODY, EXCESSIVE RESISTANCE WAS NOTED. THE DEVICE WAS THEN REPLACED WITH A PED2-450-20 DENSE MESH FLOW-DIVERTING STENT. UNDER GUIDEWIRE NAVIGATION, THE MICROCATHETER WAS ADVANCED TO THE DISTAL M1 SEGMENT. AFTER THOROUGH HYDRATION OF THE DENSE MESH FLOW-DIVERTING STENT, THE PROTECTIVE SHEATH WAS ADVA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23805043 ↗

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-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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