PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284442), received between Jan 30, 2024 and Oct 24, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23384452 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WAS DIAGNOSED WITH BACTERIAL SINUSITIS POST PROCEDURE. THE PATIENT HAD SHARP HEADACHE PAIN WHEN COUGHING OR SNEEZING. PAIN SHARP AND GONE WHEN DONE COUGHING OR SNEEZING. THE EVENT DID NOT RESULT IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS AND DID NOT RESULT FROM A DEVICE DEFICIENCY. THE EVEN RESULTED IN MEDICATION- AMOXICILLIN-CLAVULANATE 875-125MG BID X7DAYS. THERE WAS NO HOSPITALIZATION. THE OUTCOME WAS RECOVERING/RESOLVING. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, SIDEWALL ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (C5) WITH A MAX DIAMETER OF 15.6MM AND A 7MM NECK DIAMETER. ANEURYSM DOME HEIGHT WAS 11.7MM AND WIDTH WAS 13.3MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 3.9MM AND PROXIMAL TO ANEURYSM WAS 4.8MM. THERE WAS COMPLETE STASIS AND NECK COVERAGE AT THE END OF THE PROCEDURE. RAYMOND AND ROY AT THE END OF THE PROCEDURE WAS CLASS 3. THE STUDY DEVICE WAS SUCCESSFULLY IMPLANTED WITH WALL APPOSITION ACHIEVED AND NO SIDE BRANCHES COVERED. THERE WAS NO DEVICE FLATTENING OR TWISTING. ANCILLARY DEVICES INCLUDE A RIST RADIAL ACCESS 071, PHENOM PLUS, AND PHENOM 027 CATHETER.

  Patient problems: Bacterial Infection; Headache; Pain; Stenosis; Vasoconstriction

  MAUDE report 21273185 ↗
• MalfunctionJan 30, 2024Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Positioning; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN MOVEMENT OCCURRED. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. TORTUOUS GENU AND ANATOMY MADE IT DIFFICULT TO ADVANCE AND RECAPTURE. THE DEVICE DID JUMP UPON RECAPTURING. IT WAS NOTED THAT A "MISHAP" OCCURRED DURING RECAPTURE. THE PUSHWIRE WAS ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610683 ↗

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-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-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-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