PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284015), received between Jan 10, 2022 and Nov 6, 2025 — classified as 1 death, 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 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.

• MalfunctionNov 6, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS ATTRIBUTED TO THE OPENING AT THE TIP OF THE STENT BEING TAPERED COMPARED TO THE DIAMETER OF THE STENT, WITH INCONSISTENT DIAMETERS AT THE FRONT AND BACK. TIP DAMAGE WAS LIKELY CAUSED BY THE TIP END NOT FULLY OPENING AND BECOMING ROUGH DUE TO REPEATED ENTRY AND EXIT FROM THE STENT CATHETER DURING MULTIPLE PUSH-PULL DEPLOYMENT ATTEMPTS. THE SECTION OF THE PIPELINE THAT DID NOT OPEN WAS THE TIP/DISTAL END, AND IT HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME OF FAILURE. NO ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE OBSERVED TIP END DAMAGE WAS DESCRIBED AS ROUGH, RATHER THAN A BREAK OR KINK. NO RESISTANCE WAS ENCOUNTERED IN ANY SECTION OF THE CATHETER, A CONTINUOUS SALINE FLUSH WAS MAINTAINED AS INDICATED IN THE IFU, AND NO DAMAGE WAS OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490616 ↗
• MalfunctionAug 22, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE SHIELD THAT FAILED TO OPEN AND HAD FISHMOUTH DEFORMATION AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF LEFT INTERNAL CAROTID ARTERY (L-ICA) TANDEM UNRUPTURED AMORPHOUS ANEURYSMS. ANEURYSMS HAD MAX DIAMETER OF 3.34MM AND 3.25MM AND NECK DIAMETERS OF 3.12MM AND 2.52MM RESPECTIVELY. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROC ATHETER WAS ADVANCED OVER A 0.14 GUIDEWIRE TO THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) M2 SEGMENT AND THE GUIDEWIRE WAS WITHDRAWN. AFTER HYDRATION, THE PIPELINE SHIELD WAS ADVANCED TO GO UPPER VIA THE PHENOM 27 MICROCATHETER. THE MICROCATHETER WAS WITHDRAWN, INITIATING PIPELINE DEPLOYMENT IN THE M1 STRAIGHT SEGMENT. HOWEVER, THE PIPELINE STENT DID NOT OPEN. IT WAS DEPLOYED FURTHER BUT THE TIP STILL DID NOT OPEN. THE PIPELINE WAS RETRIEVED AND DEPLOYED AGAIN BUT THE FAILURE WAS STILL NOT RESOLVED. THE INTERMEDIATE CATHETER WAS PUSHED TO GO UPPER AND TO TRY AND DEPLOY THE PIPELINE SUFFICIENTLY, THE SYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874444 ↗
• DeathJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO PIPELINE FLEX SHIELDS WERE USED WITHOUT ISSUE AND FOLLOW UP IMAGING CONFIRMED EXCELLENT PLACEMENT AND APPOSITION. AS THE SYSTEM WAS REMOVED AFTER DEPLOYMENT IT APPEARED THAT THE STRESS ON THE VESSEL CAUSED THE VESSEL TO RE-RUPTURE. AFTER THE ANEURYSM RUPTURED THE ENTIRE RIGHT SIDE OF THE ANTERIOR CIRCULATION SHUT DOWN. THE PATIENT IS DECEASED. THE PATIENT WAS BEING TREATED FOR A RUPTURED FUSIFORM ANEURYSM IN THE RIGHT A2 LOCATION. THE MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 20MM. THE DISTAL LANDING ZONE WAS 2.6MM AND THE PROXIMAL LANDING ZONE WAS 2.8MM. VESSEL TORTUOSITY WAS MINIMAL. THE PIPELINE WAS USED FOR A INDICATION THAT WAS NOT APPROVED: A2. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU). ANGIOGRAPHIC RESULT POST PROCEDURE; BOTH ACA AND MCA WERE COMPLETELY CLOTTED.

  Patient problems: Obstruction/Occlusion; Rupture

  MAUDE report 13215310 ↗

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-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-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-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