PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000284398), received between Jul 21, 2021 and Mar 23, 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 23, 2026Structural Problem; Activation, Positioning or Separation Problem; Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT OF PIPELINE STENT MIGRATION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED, OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 18 MM AND A 9.2 MM NECK DIAMETER. THE LANDING ZONE WAS 3.7 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT A STANDARD PLATELET REACTIVITY UNITS (PRU) LEVEL. IT WAS REPORTED THAT THE OPERATOR HAD ALREADY DEPLOYED ONE PIPELINE SHIELD 400-35 STENT. AFTER COMPLETING COIL EMBOLIZATION, ANGIOGRAPHY SHOWED THAT THE ANEURYSM NECK WAS NO LONGER VISIBLE. THE ECHELON WAS THEN REMOVED, AND A GUIDEWIRE WAS ADVANCED THROUGH THE MARKSMAN TO MASSAGE THE STENT AND ENSURE ADEQUATE WALL APPOSITION. THE GUIDEWIRE ENTERED THE STENT IN A LOOPED CONFIGURATION, AT THIS MOMENT, THE TIP END OF THE STENT SLIPPED DOWN. THE OPERATOR WITHDREW THE GUIDEWIRE AND DID NOT ATTEMPT FURTHER MASSAGE. ON OBSERVATION, THE TIP END OF THE STENT WAS NOTED TO BE VERY CLOSE TO THE ANEURYSM NECK, RAISING CONCERN ABOUT INSUFFICIENT ANCHORING AND A POTENTIAL RISK OF FURTHER STENT MIGRATION. TO ENSURE PATIENT SAFETY, THE OPERATOR DEPLOYED AN ADDIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663210 ↗
• MalfunctionJul 21, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PHENOM 27 MICROCATHETER THAT HAD DIFFICULTY NAVIGATING TO THE INTENDED LOCATION AND A PIPELINE WITH SHIELD THAT FAILED TO OPEN IN THE MIDDLE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED GIANT SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 20MM AND THE NECK DIAMETER WAS 7MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). INITIAL ACCESS THROUGH THE ANEURYSM WITH THE PHENOM 27 MICROCATHETER IN THE DISTAL M1. THE PHYSICIAN HAD TO GO THROUGH THE ANEURYSM AND AROUND TO GET THE CATHETER DISTAL TO THE ANEURYSM. THE PHYSICIAN WAS UNABLE TO REDUCE THE LOOP FORMED IN THE PHENOM CATHETER PRIOR TO PIPELINE PREPARATION AND ADVANCEMENT INTO THE PHENOM MICROCATHETER. ONCE THE PIPELINE WAS ADVANCED AND PARTIALLY OPENED IN THE M1 SEGMENT, THE LOOP OF THE PHENOM MICROCATHETER IN THE ANEURYSM WAS ABLE TO BE REDUCED. WHEN THE CATHETER NO LONGER LOOPING INSIDE THE ANEURYSM, THE PHENOM MICROCATHETER AND PHENOM WERE PULLED BACK TO THE DISTAL LANDING ZONE. DURING DEPLOYME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204912 ↗

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-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-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