Pipeline TM Flex Embolization Device with Shield Technology TM PED2-400-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000449186), received between Jan 12, 2026 and Apr 24, 2026 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Retraction Problem; Structural Problem; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED LEFT CLINOID C5 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.3 MM AND A 3.0 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7.8MM DIAMETER. THE LANDING ZONE WAS 3.1MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS NORMAL. IT WAS REPORTED THAT AFTER THE OPERATOR ESTABLISHED ACCESS, A PHENOM 27 MICROCATHETER WAS POSITIONED IN PLACE. A SHIELD PED400-18 DEVICE WAS UNPACKED AND HYDRATED. THE DISTAL END OF THE DEVICE WAS ADVANCED THROUGH THE Y-VALVE TO THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. WHILE THE ASSISTANT ADVANCED THE DELIVERY WIRE TO ITS FULL EXTENT, VERY LITTLE RESISTANCE WAS NOTED. THE DISTAL END OF THE DEVICE WAS UNABLE TO ENTER THE PROXIMAL/TAIL END OF THE PHENOM 27 MICROCATHETER. THE OPERATOR THEN WITHDREW THE ENTIRE DEVICE ONTO THE TABLE AND ATTEMPTED TO ADVANCE THE DELIVERY WIRE BACK AND FORTH; HOWEVER, THE STENT REMAINED STATIONARY. IT WAS SUBSEQUENTLY NOTED THAT THE DEVICE HAD BECOME DETACHED (DEVICE DETACHMENT). THE OPERATOR THEN REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982287 ↗
• MalfunctionJan 12, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FLEX STENT FAILED TO OPEN IN THE DISTAL END. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. IT HAD A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS THE POSTERIOR COMMUNICATING SEGMENT OF THE INTERNAL CAROTID ARTERY, AVOIDING THE ANTERIOR AND POSTERIOR COMMUNICATING ARTERIES, AND IN THE C5 REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE PATIENT HAS A MEDICAL HISTORY OF STAGE 2 HYPERTENSION. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 100 MG ASPIRIN, 75 MG OF CLOPIDOGREL, WHICH WERE GIVE DAILY FOR 5 DAYS, PRIOR TO SURGERY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS OF AN ANEURYSM OF THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. IT WAS REPORTED THAT ON (B)(6) 2026, THE OPERATOR PERFORMED A FLOW-DIVERTING STENT IMPLANTATION FOR AN ANEURYSM AT THE OPHTHALMIC SE GMENT OF THE INTERNAL CAROTID ARTERY. A PHENOM 27 CATHETER WAS USED, AND THE PED2-400-16 STENT WAS SELECTED. A 6F NAVIEN GUIDE WIRE WAS USED TO DELIVER THE PHENOM 27 CATHETER TO THE M1 SEGM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036357 ↗

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-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-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-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