Pipeline PED-450-25 (UDI 00836462015852)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015852), received between Jun 6, 2019 and Sep 1, 2020 — 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 16, 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.

• MalfunctionSep 1, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FAILED TO OPEN AND ANOTHER BECAME STUCK AT THE HUB OF THE MARKSMAN CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR CURVATURE OF THE CAVERNOUS SINUS SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 13.5MM AND A 5.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE GUIDEWIRE WAS USED TO PLACE THE MARKSMAN MICROCATHETER AT THE DISTAL END OF THE ANEURYSM. THE GUIDEWIRE WAS THEN WITHDRAWN, AND A PIPELINE (PLI-10) WAS SMOOTHLY DELIVERED TO THE MARKSMAN TIP. DURING DEPLOYMENT, IT COULD BE SEEN THAT THE DISTAL TIP OF THE STENT WAS POORLY OPENED AND HAD A HORN-SHAPE. THE PIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% WAS DEPLOYED, AND RESHEATHING WAS PERFORMED LESS THAN 3 TIMES. AFTER A SERIES OF STENT DEPLOYMENT OPERATIONS, THE OPENING OF THE PIPELINE HAD NOT IMPROVED AND IT WAS WITHDRAWN. THE TIP WAS VISIBLY ROUGH AND DAMAGED. A SECOND PIPELINE WAS THEN SELECTED FOR USE (PLI-20), AND AFTER HYDRATING PER THE INSTRUCTIONS FOR USE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10476352 ↗
• MalfunctionJun 6, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL END OF THE PIPELINE FLEX EXPERIENCED DEPLOYMENT ISSUES. THIS EVENT OCCURRED WHEN THE PIPELINE WAS ABOUT 50% OUT OF THE CATHETER. THE PIPELINE WAS RE-SHEATHED AND REMOVED WITH THE CATHETER. THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 20MM. IT IS UNKNOWN IF THE ANATOMY WAS TORTUOUS OR AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED. THE DEVICES WERE DISCARDED AT THE SITE. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677298 ↗

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-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-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-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-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