Pipeline TM Flex Embolization Device with Shield Technology TM PED2-450-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000449384), received between Nov 7, 2025 and Sep 28, 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.

• MalfunctionSep 28, 2026Activation Failure

  Medtronic received a report that the Pipeline failed to open. The patient was undergoing intracranial aneurysm flow diverter implantation for treatment of a saccular, unruptured aneurysm located in the C4 segment of the left internal carotid artery with a max diameter of 20 mm and a 6 mm neck diameter. Landing Zone: Distal: 3 mm and Proximal: 4.4 mm. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet treatment was administered. The PRU level met the standard. The accessed vessel was the femoral artery with a diameter of 7 mm. The angiographic result post procedure showed an intracranial giant aneurysm of the C4 segment. It was reported that the Pipeline flow diverter stent could not be opened. The Pipeline was used for an indication that is on label. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). The catheter was flushed as indicated in the IFU. No patient symptoms or further complications were reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916029 ↗
• MalfunctionMar 30, 2026Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. FOR THE PED2-450-18, IT WAS REPORTED THAT THE CAUSES AND CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN AND BRAID DAMAGE WERE NOT IDENTIFIED. THE BRAIDED WIRES OF THE PED2-450-18 STENT TIP END WERE INTERWOVEN WITH EACH OTHER. IF THEY BECOME MISALIGNED, THIS IS WHAT WE CALL ¿SEPARATED¿. FROM FLUOROSCOPY, IT APPEARED THAT THIS MIGHT HAVE BEEN THE CASE. THE PED2-450-18 STENT WAS FULLY RETRIEVED AFTER DEPLOYMENT AND THEN REDEPLOYED, BUT IT STILL WAS NOT A NORMAL CONFIGURATION. FOR THE PED2-450-20, IT WAS REPORTED THAT THE CAUSES AND CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN AND KINK WERE NOT IDENTIFIED. IT IS UNCERTAIN IF THERE IS ANY DEVICE ISSUE WITH THE PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713508 ↗
• MalfunctionJan 30, 2026Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDED PUSHING, PULLING, SWINGING, RETRIEVING, AND RE-DEPLOYING, BUT NO OTHER DEVICE WAS USED TO OPEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225611 ↗
• MalfunctionJan 6, 2026Material Deformation; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF A PIPELINE DEVICE TIP FAILED TO OPEN AND APPEARED INTERTWINED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE ANEURYSM HAD A MAX DIAMETER OF 5MM, 4MM NECK DIAMETER, AND A LANDING ZONE OR ARTERY SIZE WAS 4.2MM DISTALLY AND 4.5MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS INTRACRANIAL ANEURYSM. IT WAS REPORTED THAT THE PIPELINE STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER EXPOSING APPROXIMATELY 7-8 MM OF THE STENT'S TIP, A WAITING PERIOD OF ABOUT 10 SECONDS ENSUED, BUT THE TIP DID NOT OPEN. THE SURGEON THEN DEPLOYED ANOTHER 12 MM OF THE STENT, BUT THE TIP STILL FAILED TO OPEN. THE SURGEON ATTEMPTED TO RETRIEVE AND RE-DEPLOY IT, PERFORMING MANEUVERS SUCH AS SHAKING AND PUSHING/PULLING, BUT THE TIP REMAINED UNOPENED. ADJUSTING THE TENSION OF THE MICROCATHETER ALSO FAILED TO OPEN IT. CONSEQUENTLY, THE STENT WAS WITHDRAWN FROM THE BODY. IT WAS FOUND THAT THE TIP OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979448 ↗
• MalfunctionDec 5, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. IT WAS IN THE STRAIGHT SEGMENT OF THE MIDDLE CEREBRAL ARTERY. AFTER ATTEMPTING TO RETRIEVE AND DEPLOY THE STENT TO A SUFFICIENT LENGTH, AND PERFORMING A PUSHING STENT OPERATION, THE STENT STILL FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 TIMES. REGARDING THE CAUSE OF THE FAILURE TO OPEN, IT WAS NOTED THAT CONSIDERING THAT THE TIP PROTECTION SHEATH DID NOT FLIP OVER, CAUSING THE STENT TO NOT OPEN, THE STENT WAS RETRIEVED AND RE-DEPLOYED, BUT IT STILL DID NOT OPEN, SUGGESTING THAT THE TIP END WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728700 ↗
• MalfunctionNov 7, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  NO NEW ADDITIONAL RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497438 ↗

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-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-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-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-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-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