Pipeline TM Flex Embolization Device with Shield Technology TM PED2-400-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000449193), received between Jan 23, 2026 and Mar 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Retraction Problem; Material Separation; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE IN THE PHENOM 27 CATHETER. THE PHENOM CATHETER WAS ALSO FOUND DAMAGED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE LEFT C5 SECTION IN THE INTERNAL C AROTID ARTERY WITH A MAX DIAMETER OF 2.4 MM AND A 3.2 MM NECK DIAMETER. LANDING ZONE: DISTAL 3.5 MM AND PROXIMAL: 4 MM. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPL ATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 1. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL VESSELS WITH CONTRAST AGENT RETENTION IN THE ANEURYSM. IT WAS REPORTED THAT DURING THE FLOW DIVERSION STENT IMPLANTATION PROCEDURE, AFTER PLACEMENT OF AN 8F SHORT SHEATH, A LONG SHEATH WAS PUSHED TO GO UPPER TO THE LEFT MCA C1 SEGMENT, FOLLOWED BY PUSHING A 5F115 NAVIEN TO GO UPPER TO THE C4 SEGMENT. THE PHENOM 27 MICROCATHETER (LOT NUMBER: 230455815) WAS THEN PUSHED TO GO UPPER TO THE DISTAL RIGHT MIDDLE CEREBRAL ARTERY, AND THE PED2-400-18 FLOW DIVERSION STENT (LOT NUMBER: D044346) WAS FULLY HYDRATED IN PREPARATION FOR DELIVERY TO THE LESION SIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680957 ↗
• MalfunctionJan 23, 2026Unintended Ejection; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN SEEMED TO BE DUE TO TWISTED OR STUCK IN THE MEDIAL SECTION. IT WAS NOTED THAT IT WAS NOT CONFIRMED THAT THE PIPELINE WAS TWISTED BUT DID LOOK LIKE IT ON IMAGING. THE DEVICE WAS PULLED OUT AND DEPLOYED IN THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161795 ↗

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