PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-275-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000283919), received between Mar 26, 2024 and Mar 26, 2024 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Structural Problem; Material Deformation; Activation Failure; Lack of Effect; Structural Problem; Material Deformation; Activation Failure; Lack of Effect

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT ANTERIOR CEREBRAL ARTERY A1 SEGMENT WITH A MAX DIAMETER OF 2.4 MM AND A 2.2 MM NECK DIAMETER. LANDING ZONE: DISTAL: 1.8 MM AND PROXIMAL: 2.6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED VASCULAR PATENCY AND NORMAL BLOOD FLOW. IT WAS REPORTED THAT WHEN TREATING THE LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM, AFTER THE MICROCATHETER WAS IN PLACE, PED2-275-14 WAS DELIVERED INTO PLACE. WHEN DEPLOYED, IT WAS FOUND THAT THE DISTAL END OF THE DENSE MESH STENT WAS POORLY OPENED AND BITTED TOGETHER. THE STENT FAILED TO BE OPENED AFTER RETRIEVAL, DEPLOYMENT, AND TENSION INCREASE AND DECREASE OPERATIONS. IT WAS SUSPECTED THAT THE BRAIDED WIRE WAS DAMAGED, AND POST-EXPANSION WAS PREPARED AFTER DEPLOYMENT. AFTER THE STENT WAS DEPLOYED, THE MICRO GUIDEWIRE MASSAGE FAILED TO FULLY OPEN THE DISTAL END OF THE STENT, CAUSING THE STENT TO SHORTEN AND FAILING TO COVER THE PROXIMAL END OF THE ANEURYSM NECK. ONLY ONE MORE PED2-275-20 WAS DEPLOYED THROUGH THE MICROCATHETER, AND THIS PED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18978583 ↗

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-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-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-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-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