PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000284107), received between Aug 6, 2025 and Aug 6, 2025 — 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.

• MalfunctionAug 6, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A DENSE MESH STENT WAS IMPLANTED FOR THE RIGHT V4 ANEURYSM. THE DIAMETER OF THE DISTAL ANCHOR POINT WAS 2.9 MM, AND THE DIAMETER OF THE VESSEL AT THE PROXIMAL LANDING POINT WAS 3.1 MM. DUE TO LIMITED MODELS, A PED2-325-25 DENSE MESH STENT WAS SELECTED FOR IMPLANTATION. THE ACCESS WAS TO USE A 6F DELIVERY CATHETER AND 6F115NAVIEN. THROUGH THE GUIDE WIRE, THE PHENOM27 STENT CATHETER WAS ADVANCED TO THE P1 SEGMENT. THE GUIDE WIRE WAS WITHDRAWN AND HIGH-PRESSURE INFUSION WAS PERFORMED FOR HYDRATION. AFTER THE DELIVERY SHEATH WAS PRESSED AGAINST THE PHENOM27 HUB, THE STENT WAS DELIVERED TO THE P1 SEGMENT. AFTER THE STENT CATHETER WAS CAME OUT, THE TIP END WAS OPENED. THE STENT TIP OPENED ABNORMALLY. AFTER LOCKING THE Y VALVE, IT WAS PULLED BACK TO THE BASILAR ARTERY AND THE STENT TIP WAS DEPLOYED AGAIN. THE STENT OPENING WAS OBSERVED UNDER FLUOROSCOPY AND STILL ABNORMAL. THE Y VALVE WAS LOCKED AND THE PUSH-PULL OPERATION WAS REPEATED, BUT THE STENT ADHERENCE TO THE WALL DID NOT IMPROVE. CONSIDERING THAT THE STENT ITSELF MAY HAVE PRODUCT QUALITY PROBLEMS, THE SURGEON CONSIDERED REPLACING THE STENT, AND THEN ADOPTED CONVENTIONAL ATALAS-ASSISTED EMBOLIZATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731143 ↗

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-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-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