Pipeline TM Flex Embolization Device with Shield Technology TM PED2-450-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000449391), received between Oct 15, 2025 and Apr 6, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE DEVICE THAT FAILED TO OPEN AND ENCOUNTERED RESISTANCE WITH A MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT SIDE OF THE C6 SEGMENT WITH A MAX DIAMETER OF 5MM AND A 4.7MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 4.3MM DISTAL AND 4.6MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7.6MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS AN, "ANEURYSM CONTRAST AGENT RETENTION." IT WAS REPORTED THAT THE ACCESS SYSTEM WAS SUCCESSFULLY ESTABLISHED, EXTENDING THE INTERMEDIATE CATHETER TO THE DISTAL C3 SEGMENT. GUIDED BY A MICRO-GUIDEWIRE, A MARKMAN STENT MICROCATHETER WAS ADVANCED TO THE RIGHT M2 SEGMENT. A 4.5*25 FLOW-DIVERTING STENT WAS THEN ADVANCED THROUGH MARKMAN AND SLOWLY DEPLOYED WITHIN THE INTERNAL CAROTID C7 SEGMENT; HOWEVER, THE SURGEON OBSERVED SUBOPTIMAL OPENING OF THE STENT'S TIP. DESPITE ATTEMPTING TO ADJUST THE POSITION TO CONTINUE DEPLOYMENT, THE TIP OF THE STEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789592 ↗
• MalfunctionNov 3, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROXIMAL VESSEL WAS TORTUOUS, CONSTRAINING THE STENT. THE RESISTANCE ENCOUNTERED DURING STENT RETRIEVAL WAS MODERATE. THE PROXIMAL SECTION OF THE PIPELINE FAILED TO OPEN. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451787 ↗
• MalfunctionOct 15, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. DURING THE DELIVERY OF THE PIPELINE DEVICE, FRICTION OR RESISTANCE WAS ENCOUNTERED. THE CATHETER WAS FLUSHED ACCORDING TO THE IFU DURING THE PROCEDURE. THE CAUSE OF THE STENT¿S FAILURE TO OPEN WAS DETERMINED TO BE AN ISSUE WITH THE STENT TIP, AND IT WAS NOTED THAT THE OVERALL VASCULAR APPROACH WAS SLIGHTLY TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23283281 ↗

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-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-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