PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000284275), received between Feb 17, 2023 and Jan 21, 2026 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE STENT NOT OPENING, EVEN AFTER RETRIEVING THE DAMAGE PART, WAS UNDETERMINED. IT WAS CLARIFIED THAT THE MIDDLE SECTION OF THE PIPELINE DID NOT OPEN, THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN, AND THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132266 ↗
• MalfunctionMar 13, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN/PIPELINE DAMAGE WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN POSITIONED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THEY HAD PUSHED THE INTERMEDIATE CATHETER TO GO UPPER IN AN ATTEMPT TO OPEN THE PIPELINE. THERE WAS NO DAMAGE OR ISSUE WITH THE PHENOM CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593388 ↗
• MalfunctionNov 22, 2024Structural Problem; Material Deformation; Activation Failure; Structural Problem; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING A PIPELINE EMBOLIZATION DEVICE, THE MIDDLE SECTION OF THE STENT BECAME KINKED DURING DEPLOYMENT. THE PROCEDURE TOOK PLACE AT THE C6 OPHTHALMIC ARTERY FOR AN UNRUPTURED, AMORPHOUS ANEURYSM WITH A MAXIMUM DIAMETER OF 4.3 MILLIMETERS AND A NECK DIAMETER OF 1.88 MILLIMETERS. THE DISTAL LANDING ZONE MEASURED 3.5 MILLIMETERS AND THE PROXIMAL LANDING ZONE MEASURED 3.77 MILLIMETERS, WITH MODERATE VESSEL TORTUOSITY. POST-PROCEDURE, SLOWED BLOOD FLOW WAS OBSERVED. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THOUGH THE PLATELET REACTIVITY UNIT LEVEL WAS UNKNOWN. THE STENT WAS RETRIEVED AND REDEPLOYED, BUT IT DID NOT OPEN PROPERLY. UPON REMOVAL FROM THE BODY, THE MIDDLE SECTION OF THE STENT WAS SLIGHTLY DEFORMED. THE STENT WAS REPLACED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758796 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED A CEREBRAL VASOSPASM. THE SUBJECT EXPERIENCED MILD TO MODERATE VASOSPASMS IN BILATERAL ICAS. THE PATIENT WAS TREATED WITH VERAPAMIL, RECOVERED APPROPRIATELY. END DATE OF THE HOSPITALIZATION: (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vasoconstriction

  MAUDE report 19203572 ↗
• MalfunctionMar 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS STUCK IN THE PHENOM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT SUPER CLINOID ICA ANEURYSM WITH A MAX DIAMETER OF 3.5MM AND A 5MM NECK DIAMETER. THE LANDING ZONE WAS 3.25MM AT THE DISTAL END AND 3.6MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITYWAS MINIMAL. THE ACCESS VESSEL WAS THE ICA WITH 3.6MM DIAMETER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED, PRU LEVEL WAS THERPEUTIC. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DEVICE WAS EXTREMELY HARD TO PUSH THROUGH THE PHENOM27, AND THE DOCTOR COULDN¿T GET IT TO EXIT THE CATHETER SO THE DOCTOR TRIED TO REMOVE THE PIPELINE THEN IT GOT STUCK IN THE CATHETER HUB - THEY REMOVED THE PHENOM AND PIPELINE. THE PIPELINE ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PIPELINE THEN BECAME STUCK AT THE CATHETER HUB DURING DELIVERY. THE PIPELINE NEVER EXITED THE CATHETER INTO THE BODY, COULDN'T GET THE DEVICE TO PUSH TO THE END OF THE CATHETER TO EXIT AND DEPLOY. THE CATHETER AND PUSHWIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601206 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT RESULTED IN A PROLONGATION OF EXISTING HOSPITALIZATION, WHICH ENDED ON (B)(6) 2022.

  Patient problems: Vasoconstriction

  MAUDE report 16399510 ↗

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-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-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