Pipeline TM Flex Embolization Device with Shield Technology TM PED2-500-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000449582), received between Nov 21, 2025 and Sep 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690516 ↗
• MalfunctionAug 26, 2026Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457076 ↗
• MalfunctionMar 25, 2026Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. RESISTANCE WAS NOTED IN THE DISTAL SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND NO ADDITIONAL STEPS OR OTHER DEVICES (SUCH AS RESHEATHING, WIRE OR CATHETER MANIPULATION, OR BALLOON USE) WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686762 ↗
• MalfunctionJan 29, 2026Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING PIPELINE FLEX WITH SHIELD EMBOLIZATION DEVICE THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER STENT TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT UNRUPTURED AMORPHOUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 5.3MM. THE DISTAL LANDING ZONE WAS 4.5MM; THE PROXIMAL LANDING ZONE WAS 4.9MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE CATHETER DELIVERY SYSTEM WAS POSITIONED IN LACE, THE PIPELINE WAS HYDRATED AND DELIVERED TO THE MIDDLE CEREBRAL ARTERY (MCA) STRAIGHT SEGMENT. THE MICROCATHETER WAS RETRACTED TO START DEPLOYMENT OF THE PIPELINE STENT. HOWEVER, THE TIP OF THE STENT DID NOT OPEN. DEPLOYMENT WAS CONTINUED WITH REPEATED PUSHING AND PULLING BUT THE TIP STILL DID NOT OPEN. THE PIPELINE WAS FULLY RESHEATHED IN THE MICROCATHETER AND REPOSITIONED AT THE PROXIMAL END OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) FOR DEPLOYMENT BUT THE PIPELINE STILL DID NOT OPEN. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209703 ↗
• MalfunctionNov 21, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PIPELINE FAILURE TO OPEN WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND IT WAS NOT RESHEATHED DURING THE PROCEDURE. NO VISIBLE DAMAGE WAS OBSERVED ON THE PHENOM 27 MICROCATHETER

  Patient problems: Vascular Dissection

  MAUDE report 23620836 ↗

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-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-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-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