Pipeline TM Flex Embolization Device with Shield Technology TM PED2-500-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000449544), received between Dec 8, 2025 and Aug 28, 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.

• MalfunctionAug 28, 2026Material Deformation; Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497250 ↗
• MalfunctionMar 6, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE PIPELINE FAILURE TO OPEN AND RESISTANCE DURING RETRIEVAL IDENTIFIED. THE PIPELINE HAS NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE ADDITIONAL STEPS AND/OR OTHER DEVICES USED TO OPEN THE PIPELINE WAS, "ATTEMPTED TO RETRIEVE AND REDEPLOY, AS WELL AS TO CHANGE THE DEPLOYMENT TECHNIQUE, ALL FAILED TO OPEN IT." THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE OR PHENOM AFTER THE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531383 ↗
• MalfunctionFeb 9, 2026Material Frayed; Use of Device Problem; Patient-Device Incompatibility; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A DAMAGED PIPELINE TIP THAT WAS DIFFICULT TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 8MM AND A 6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENTS MEDICAL HISTORY INCLUDES AN ANEURYSM HAD PREVIOUSLY RUPTURED AND CAUSED BLEEDING. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS WITHIN TARGET RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS BILATERAL ANEURYSMS: MULTIPLE ANEURYSMS ON THE LEFT SIDE, AN IRREGULAR ANEURYSM ON THE RIGHT SIDE, AND THE RIGHT SIDE HAD PREVIOUSLY RUPTURED AND BLED. THE LANDING ZONE (ARTERY SIZE) WAS 3.9MM DISTALLY AND 4.2MM PROXIMALLY. IT WAS REPORTED THAT THIS PATIENT HAD BILATERAL ANEURYSMS, WITH THE RIGHT SIDE HAVING PREVIOUSLY RUPTURED AND BLED, AND A DAUGHTER SAC WAS PRESENT. THEREFORE, IT WAS DECIDED TO TREAT THE RIGHT SIDE FIRST. DUE TO THE PRESENCE OF A DAUGHTER SAC AND PREVIOUS RUPTURE, 11 COILS WERE USED FOR EMBOLIZATION, FOLLOWED BY STENT DEPLOYMENT. THE WIDEST PART OF THE ANEURYSM WAS NEAR THE NECK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296678 ↗
• MalfunctionFeb 5, 2026Use of Device Problem; Patient-Device Incompatibility; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF TWO PIPELINE DEVICES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C7 SEGMENT WITH A MAX DIAMETER OF 6MM AND A 5MM NECK DIAMETER. THE LANDING ZONE OR ARTERY SIZE WAS 4.7MM DISTAL AND 5.1MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS ANEURYSM SHOWED SIGNIFICANT CONTRAST AGENT RETENTION, WITH NO VASCULAR LOSS. IT WAS REPORTED THAT THERE WAS A SLIGHT ISSUE WITH THE SIZE OF THIS BATCH OF STENTS. SPECIFICALLY, THE OPERATOR PERFORMED BOTH 2D AND 3D MEASUREMENTS AND SELECTED A PED2-500-18 STENT. AFTER THE ASSISTANT PLACED IT IN POSITION, STENT DELIVERY BEGAN. THE PHENOM 27 REACHED THE M2 SEGMENT, STENT DELIVERY WAS STARTED, ONCE THE MAIN PART OF THE STENT REACHED THE STRAIGHT SEGMENT OF THE M1 MIDDLE CEREBRAL ARTERY, STENT DEPLOYMENT WAS INITIATED. THE MICROCATHETER WAS WITHDRAWN TO DEPLOY THE TIP OF THE STENT, WITH APPROXIMATELY 8 MM RETRACTION OF THE MICROCATHETER, BUT THE STENT DID NOT OPEN. THE OPERATOR REPORTED WAITING FOR ABOUT ONE MINUTE, BUT THE TIP OF THE STENT STI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269056 ↗
• MalfunctionDec 8, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING, THE ONLY ISSUE WAS THE DISTAL OPENING. IT WAS NOTED THAT UPON REMOVING THE PIPELINE STENT THAT WOULD NOT DEPLOY, THE DEVICE WAS TRAPPED IN THE HUB OF THE MICROCATHETER UPON REMOVAL. IT WAS NOTED THAT THERE WAS NO RESISTANCE IN THE CATHETER DURING RETRIEVAL AND THERE WAS NO RESISTANCE INSIDE THE PIPELINE SHEATH. UPON REMOVAL AFTER THE PIPELINE WOULD NOT OPEN AND THE DOCTOR WAS GOING TO SWITCH IT TO ANOTHER STENT IS WHEN THE STENT BECAME STUCK. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751183 ↗

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-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-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-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