PIPELINE PED-400-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536015814), received between Oct 25, 2018 and Apr 16, 2021 — classified as 1 injury, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2021Break; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN THE FAILURE TO OPEN OCCURRED. THE PHYSICIAN NOTICED RESISTANCE UPON DELIVERY OF THE DEVICE WITH TWO ATTEMPTS TO RESHEATH AND DELIVERY OF THE DEVICE UPON NOTICING THAT PHYSICIAN HAD NO CONTROL OVER THE DEVICE DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680900 ↗
• MalfunctionDec 1, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE STENT WAS NOT DEPLOYED IN A BEND, AND RESHEATHING WAS ATTEMPTED ONCE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924826 ↗
• MalfunctionMay 22, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FAILED TO DEPLOY AND TWO DELIVERY SYSTEMS BECAME STUCK UPON REMOVAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LEFT, SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE FIRST PIPELINE WAS DELIVERED TO THE DISTAL ICA TERMINUS. THE WIRE WAS RETRIEVED, AND UPON PULLING OUT THE WIRE, IT BECAME STUCK IN THE MIDDLE SEGMENT OF THE PHENOM 27 MICROCATHETER. EVERYTHING WAS REMOVED, A SECOND PHENOM 27 WAS DELIVERED FOLLOWED BY A SECOND PIPELINE. THE PIPELINE BECAME TWISTED AND WOULD NOT STRAIGHTEN OUT OR OPEN AFTER NUMEROUS RE-SHEATHING AND RE-DEPLOYMENT ATTEMPTS. UPON REMOVAL, THE PIPELINE BECAME STUCK ABOUT HALFWAY, AND THE ENTIRE SYSTEM WAS REMOVED. A THIRD PHENOM 27 WAS USED AND SUCCESSFULLY DELIVERED THE SECOND PIPELINE INTO THE PATIENT SUCCESSFULLY TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NEURON MAX AND NAVIEN 58.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10084131 ↗
• InjuryDec 15, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING DEPLOYMENT OF THE PIPELINE (PED), THE PIPELINE WOULD NOT OPEN DISTALLY. AFTER MULTIPLE ATTEMPTS OF TRYING TO GET THE PIPELINE TO OPEN, THE PIPELINE WAS REMOVED IN ANTICIPATION OF USING A DIFFERENT PIPELINE OF THE SAME SIZE. AFTER REMOVAL OF PIPELINE, AN ANGIOGRAM WAS TAKEN, AND CLOT WAS FOUND IN LOCATION OF INTENDED DISTAL LANDING ZONE OF PIPELINE. THERE WAS ALSO EITHER VASOSPASM OR CLOT IN SUPERIOR DIVISION OF MCA. THE PATIENT WAS GIVEN INTEGRILIN TO TREAT CLOT. CLOT APPEARED TO RESOLVE. DEVICE IS BEING SENT BACK DUE TO ITS INABILITY TO OPEN CORRECTLY IN VESSEL. WHEN DEVICE WAS INSPECTED ON TABLE, IT APPEARED TO BE SLIGHTLY DEFORMED IN SHAPE. THE PED¿S DISTAL SECTION WAS PLACED IN A BEND IN THE ANATOMY. MORE THAN 50% OF THE DEVICE WAS DEPLOYED. THE PED WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PED WAS RESHEATHED WITH THE PHENOM 27 CATHETER AND REMOVED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE. A NEW DEVICE WAS USED TO TREAT THE PATIENT. POST PROCEDURE ANGIOGRAPHY SHOWED MINIMAL CHANGES FROM PREVIOUS ANGIO. THE PATIENT WAS ON DUAL ANTIPLATELET TREATMENT. THE PATIENT WAS UNDERGOING TREATMENT OF A PREVIOUSLY RUPTURE

  Patient problems: Thrombosis; Vasoconstriction

  MAUDE report 9471159 ↗
• MalfunctionOct 25, 2018Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN ATTEMPTING TO DEPLOY THE PIPELINE IT MIGRATED PROXIMAL TO THE ANEURYSM. AS A RESULT THE PHYSICIAN ATTEMPTED TO RESHEATH THE DEVICE TO MOVE THE WHOLE SYSTEM FORWARD AND COVER THE NECK OF THE ANEURYSM BUT IT WOULD NOT RESHEATH. THE PRODUCT WAS THEN REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER OF THE SAME MODEL WHICH DEPLOYED AS EXPECTED WITH NO COMPLICATIONS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A DISTAL ICA ANEURYSM. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005141 ↗

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-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-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-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-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-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