Pipeline TM Flex Embolization Device with Shield Technology TM PED2-475-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000449483), received between Dec 1, 2025 and Aug 10, 2026 — classified as 6 malfunctions.

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

• MalfunctionAug 10, 2026Material Frayed; Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50193242 ↗
• MalfunctionApr 2, 2026Use of Device Problem; Improper or Incorrect Procedure or Method; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE POSTERIOR CEREBRAL ARTERY WITH A MAX DIAMETER OF 4.3MM AND A 3.8MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) 3.6MM DISTAL AND 3.8MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS, "THE ANEURYSM ISSUE WAS PERFECTLY RESOLVED POSTOPERATIVELY, AND THE DENSE MESH FLOW-DIVERTING STENT WAS WELL OPPOSED TO THE VESSEL WALL." IT WAS REPORTED THAT THE DEVICE WAS ADVANCED THROUGH A NORMAL ACCESS ROUTE TO THE LESION SITE, AND THE DENSE MESH FLOW-DIVERTING STENT WAS THEN DEPLOYED. DURING DEPLOYMENT, THE PROXIMAL END OF THE DENSE MESH FLOW-DIVERTING STENT WAS UNABLE TO FULLY DEPLOYED. DESPITE MANIPULATION TECHNIQUES SUCH AS COMBINED PUSHING AND PULLING, THE TIP END OF THE STENT COULD NOT BE FULLY OPENED. IT WAS NOTED THAT THERE WAS FAILURE TO OPEN IN THE PROXIMAL SECTION OF THE DEVICE. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765731 ↗
• MalfunctionMar 5, 2026Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523740 ↗
• MalfunctionJan 21, 2026Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE EVENT IS UNCERTAIN, BUT IT IS SUSPECTED THAT DAMAGE TO THE DISTAL END OF THE STENT AFFECTED ITS DEPLOYMENT AND PREVENTED IT FROM FULLY OPENING. SPECIFIC OPERATIONS WERE PERFORMED IN AN ATTEMPT TO OPEN THE DISTAL END, INCLUDING RETRIEVAL AND REDEPLOYMENT OF THE STENT IN THE STRAIGHT M1 SEGMENT AND MANIPULATION BY THE SURGEON; HOWEVER, THE DISTAL END REMAINED UNOPENED. THE PROCEDURE WAS COMPLETED BY REPLACING THE PIPELINE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133649 ↗
• MalfunctionJan 16, 2026Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. TO ADDRESS THE ISSUE, THE INTERMEDIATE CATHETER WAS PUSHED FURTHER UP. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100649 ↗
• MalfunctionDec 1, 2025Material Deformation; Material Twisted/Bent; Activation Failure; Material Deformation; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE ACCESS WAS IN PLACE, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DELIVERED TO THE IPSILATERAL M1, EXPOSING THE STENT TIP BY APPROXIMATELY 7-8 MM. AFTER WAITING FOR ABOUT 10 SECONDS, THE STENT TIP DID NOT OPEN. THE STENT WAS THEN DEPLOYED FURTHER BY ABOUT 12 MM, BUT THE TIP STILL FAILED TO OPEN. THE STENT WAS RETRIEVED AND DEPLOYED AGAIN, HOWEVER, AFTER SHAKING, PUSHING, AND PULLING, THE TIP STILL DID NOT OPEN. ADJUSTING THE MICROCATHETER TENSION AND OTHER OPERATIONS ALSO FAILED TO OPEN THE STENT. THE STENT WAS WITHDRAWN FROM THE BODY, AND IT WAS DISCOVERED THAT THE STENT TIP WAS INTERTWINED. THE STENT AND MICROCATHETER WERE REPLACED WITH MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 7 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 4.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 6 MM. DUAL ANTIPLATELET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686100 ↗

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-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-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-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