Pipeline PED-475-25 (UDI 00836462015883)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462015883), received between Apr 29, 2019 and Oct 13, 2020 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE TIP OF THE STENT WAS REPEATEDLY PUSHED AND PULLED, BUT STILL COULD NOT BE OPENED. IT WAS NOTED THE STENT WAS NOT POSITIONED IN A BEND, MORE THAN 50% OF THE STENT WAS DEPLOYED, RE-SHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL STEPS OR DEVICES WERE USED IN AN ATTEMPT TO OPEN THE PIPELINE. A REPLACEMENT STENT WAS USED 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. POST-PROCEDURE ANGIOGRAPHY SHOWED SLOWED BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS WITH A MAX DIAMETER OF 5.87 MM AND A 4.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS AD MINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UP TO STANDARD. MEDICAL HISTORY INCLUDES: HYPERTENSION, HYPERGLYCEMIA (DIABETES) AND HYPERLIPIDEMIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10673058 ↗
• MalfunctionApr 29, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARKSMAN CATHETER BEING USED TO DELIVER A PIPELINE THAT COULD NOT OPEN AND DAMAGE WAS FOUND TO BOTH DEVICES. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 5.35MM AND THE NECK DIAMETER WAS 5.27MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AFTER ONE PIPELINE DEVICE FAILED TO OPEN AND WAS REMOVED WITH THE CATHETER AND BOTH HAD BECAME DAMAGED, BOTH DEVICES WERE REPLACED AND THE PROCEDURE REATTEMPTED. WHEN THE MARKSMAN CATHETER REACHED THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, THE PIPELINE FLEX WAS BEING DELIVERED, THE SURGEON WITHDREW THE MARKSMAN TO THE FLAT SEGMENT OF M1, AND RELEASED ABOUT 7-8MM OF THE PIPELINE. THE TIP OF PIPELINE COULD NOT BE OPENED, THE SURGEON TRIED TO MOVE IT FORWARD AND BACKWARD, RESHEATH AND REDELIVER MANY ATTEMPTS BUT STILL FAILED. THE PIPELINE FLEX SHOWED DAMAGED BURRS AT THE TIP UNDER DEVELOPMENT. THE CATHETER TIP WAS DEFORMED AND FLAT. WHEN THE CATHETER WAS WITHDRAWN FROM THE PATIENT'S BODY, IT DEVELOPED AN ACCORDION SHAPE. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010668 ↗
• MalfunctionSep 12, 2019Break; Unintended Ejection; Physical Resistance/Sticking; Break; Unintended Ejection; Physical Resistance/Sticking

  PHYSICIAN CONTINUED PUSHING UNTIL THE RESISTANCE SUDDENLY DISAPPEARED, SO THEY REMOVED THE DEVICE DURING WHICH IT WAS FOUND THAT THE PIPELINE HAD DISENGAGED FROM THE PUSHER WHILE INSIDE THE MICROCATHETER. DAMAGE WAS SEEN ON THE CENTRAL PART OF THE PUSHWIRE AND IT SEEMED THE MICROCATHETER WAS IN AN ACCORDION SHAPE. THE PATIENT WAS UNDERGOING SURGERY FOR AN UNRUPTURED, SACCULAR LEFT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 16MM AND A NECK DIAMETER OF 6MM. IT IS UNKNOWN IF DUAL ANTIPLATELET THERAPY WAS PERFORMED. THERE WERE NO RELATED PATIENT SYMPTOMS. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE, THE DEVICES WERE PREPARED AS INDICATED PER THE IFU, A CONTINUOUS FLUSH WAS USED. THERE WAS NO DAMAGE TO THE DELIVERY PUSHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9009321 ↗
• MalfunctionApr 29, 2019Migration; Migration

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX MIGRATION DURING A PROCEDURE. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT OF A RUPTURED BLISTER ANEURYSM IN OPHTHALMIC SEGMENT OF INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM WAS REPORTED TO HAVE A MAX DIAMETER AND A NECK DIAMETER OF 2MM. THE LANDING ZONE WAS 3.8MM DISTALLY AND 4.3MM PROXIMALLY. THE ANATOMY WAS REPORTED TO HAVE BEEN NORMAL IN TORTUOSITY. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE DELIVERY OF THE DEVICES. USING STANDARD INTERVENTION TECHNIQUES, ACCESS WAS GAINED TO THE ANEURYSM. THE PED 475-25 WAS ADVANCED INTO CATHETER UNTIL THE DISTAL MARKER OF PED MATCHED WITH DISTAL MARKER OF CATHETER. THE ENTIRE SYSTEM WAS DRAGGED INTO THE STRAIGHT SEGMENT OF M1 & STARTED DEPLOYING THE PED WHICH DEPLOYED WELL. IT WAS THEN DECIDED TO TRACK THE CATHETER OVER THE DELIVERY WIRE OF PED TO CAPTURE TIP OF THE WIRE OF PED. WHILE PUSHING THE CATHETER THE DEPLOYED PED FORESHORTENED DISTALLY AND FALLEN DOWN MISSING THE NECK OF THE ANEURYSM, AS NECK OF THE ANEURYSM WAS UNCOVERED WITH PED. IT WAS DECIDED TO PLACE ANOTHER PED TO TELESCOPE THE DEVICES/ VESSEL. THERE WE

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8559717 ↗

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-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-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-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