Pipeline PED-500-25 (UDI 00836462015913)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00836462015913), received between May 13, 2019 and May 11, 2021 — 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.

• MalfunctionMay 11, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO IMAGES AVAILABLE FOR REVIEW. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE, AND WHEN THE DEVICE WAS OUTSIDE OF THE BODY, THE MID PORTION WAS STILL NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805336 ↗
• MalfunctionDec 21, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING FOUR PIPELINE DEVICES THAT FAILED TO OPEN. THE PATIENT WAS UNDERGOING A FLOW DIVERSION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE CAVERNOUS SEGMENT OF AN INTERNAL CAROTID ARTERY (ICU). THE ANEURYSM MAX DIAMETER WAS 14MM AND THE NECK DIAMETER WAS 8MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH NOTED PRU LEVEL OF 160. IT WAS REPORTED THAT AN ATTEMPT WAS FIRST MADE WITH A PIPELINE (MODEL: PED-500-25, LOT: A718991). THE PIPELINE WAS ADVANCED THROUGH THE PHENOM-27 150CM MICROCATHETER WITH SOME RESISTANCE. DURING THE INITIAL DEPLOYMENT WITH THE MIDDLE SECTION OF THE PIPELINE POSITIONED IN A VESSEL BEND, THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED. NO ADDITIONAL STEPS WERE TAKEN TO TRY AND OPEN THIS PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THROUGH THE PHENOM CATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED RELATED TO THE EVENT. POST-PROCEDURE ANGIOGRAPHY REVEALED NO ISSUE. THE ANEURYSM REMAINED UNRUPTURED AND THERE WAS NO EVIDENCE OF DAMAGE FROM THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047419 ↗
• MalfunctionJan 13, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT DEPLOYMENT ISSUES WERE ENCOUNTERED WITH THE PIPELINE FLEX AND THAT THE PIPELINE WAS BROKEN. THE PATIENT WAS REPORTED TO HAVE BEEN TREATED FOR A POST TRAUMATIC AUTOMOBILE ACCIDENT THAT RESULTED IN A LEFT, PROXIMAL, INTERNAL CAROTID ARTERY (ICA) PSEUDOANEURYSM /FISTULA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580320 ↗
• MalfunctionMay 13, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE WHEN ADVANCED THROUGH THE MICROCATHETER. THE PIPELINE WAS DIFFICULT TO PLACES. THE PIPELINE WAS DEPLOYED FROM C2 TO CAVERNOUS SINUS SITE AND IT DID NOT DEPLOY WELL. THE DEVICE WAS ATTEMPTED TO BE RESHEATHED, HOWEVER, THE DEVICE ENCOUNTERED RESISTANCE AND THE DEVICE WAS UNABLE TO BE RESHEATHED. THE PIPELINE FELL (MIGRATED) FROM THE DISTAL DEPLOYMENT POSITION, WHICH MADE IT DIFFICULT TO PLACE. THE PIPELINE WAS REMOVED FROM THE PATIENT. UPON ASSESSMENT OF THE REMOVED DEVICE, THE DISTAL PART OF THE STENT WAS BROKEN, AND THE MICROCATHETER CORRUGATED (ACCORDIONED). THE ANEURYSM WAS IN THE LEFT INTERNAL CAROTID ARTERY - FROM C3 TO C4. THE ANEURYSM WAS UNRUPTURED, AMORPHOUS AND THE NECK WIDTH WAS 10MM OR MORE. THE LANDING ZONE WAS ABOUT 3.87 MM DISTALLY AND ABOUT 5.22 MM PROXIMAL. THE ANATOMY WAS SEVERELY TORTUOUS AND ARTERIOSCLEROSIS, AND IT WAS VERY DIFFICULT TO OPERATE PIPELINE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. A CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. THE DEVICES WERE EACH PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT HARM: NO. VESSEL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8603911 ↗

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