PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000284220), received between Aug 3, 2022 and Mar 28, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2024Positioning Failure; Retraction Problem; Malposition of Device; Physical Resistance/Sticking; Positioning Failure; Retraction Problem; Malposition of Device; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE ENCOUNTERED RESISTANCE IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) BETWEEN THE PCOM AND OPHTHALMIC WITH A MAX DIAMETER OF 2.5MM AND A 2.5MM NECK DIAMETER. THE LANDING ZONE WAS 3.6MM DISTALLY AND 3.8MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THEY STARTED DEPLOYMENT IN THE M2 EXPOSING BRAID AND IT OPENED UP NICELY LIKE NORMAL, THEN THE DOCTOR DRAGGED THE DEVICE DOWN TO THE TERMINUS ENDED UP TOO PROXIMAL OF THE DESIRED DISTAL LANDING ZONE. NEEDING TO ADJUST, THE DOCTOR RECAPTURED THE TIP COIL, THEN ADJUSTED HIS POSITION AND THEY TRIED TO UN-SHEATH TIP COIL. THE DOCTOR SAID HE HAD VERY HARD RESISTANCE AND THE DEVICE WOULD NOT RE-DEPLOY OUT OF THE PHENOM 27. HE PULLED OUT THE PHENOM 27 SYSTEM WITH THE DEVICE STILL INSIDE. THE DOCTOR STARTED OVER WITH NEW PHENOM 27 AND NEW DEVICE 3.75X14 WHICH DEPLOYED LIKE NORMAL WITH NO ISSUES. IT WAS NOTED THAT THE PIPELINE WAS STUCK IN THE CATHETER IN THE DISTAL SECTION DURING RESHEATHING. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PHY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000081 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE HAD COMPLICATIONS. SUDDEN VISION LOSS OF THE LEFT EYE ON (B)(6) 2022 AT 06:26 PM AND BURNING HEADACHE ON THE LEFT SIDE OF THE HEAD 10/10 IN INTENSITY. THE PATIENT WAS ADMITTED TO EMERGENCY DEPARTMENT CTA BRAIN IMAGING WAS UNREMARKABLE. WITHOUT STENT MIGRATION, VISION IMPROVED WITH BASELINE NORMAL VISUAL ACUITY. THE EVENT RESOLVED ON (B)(6) 2022. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO ANTIPLATELET MEDICATION, RETREATMENT PROCEDURE OR STUDY DEVICE. THE PATIENT WAS BEING TREATED FOR A SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) C6 SIDEWALL. MAXIMUM ANEURYSM DIAMETER: 7 MM. ANEURYSM DOME HEIGHT: 5 MM. ANEURYSM DOME WIDTH: 6 MM. ANEURYSM NECK SIZE: 4 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.1 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 4.3 MM. SIGNIFICANT STASIS AT THE END OF THE PROCEDURE. COMPLETE NECK COVERAGE AT THE END OF THE PROCEDURE. RAYMOND AND ROY CLASS 1 OCCLUSION AT THE END OF THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED REPORTED NO INTERVENTION WAS PERFORMED TO RESOLVE THE SYMPTOMS. THE PATIENT HAD A FOLLOW UP VISIT BY OPHTHALMOLOGIST ON (B)

  Patient problems: Headache; Loss of Vision; Stroke/CVA

  MAUDE report 15158912 ↗

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-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-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-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