PIPELINE PED-500-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536016866), received between Dec 3, 2019 and Apr 28, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

1. Jul 13, 2021Class IOpen, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WENT TO RECAPTURE THE PIPELINE DEVICE WITH THE PHENOM CATHETER DURING DEPLOYMENT AND IN THE PROCESS, IT BECAME STUCK AND EVENTUALLY BROKE AT THE POINT OF PUSHER AND RESHEATHING PAD. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. A NEW PIPELINE AND CATHETER WERE USED AND SUCCESSFULLY DEPLOYED. THERE WAS A SLIGHT DELAY IN THE CASE, AND THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740171 ↗
• MalfunctionSep 14, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE DID NOT ACHIEVE FULL WALL APPOSITION INITIALLY, AND THE SECOND PIPELINE FAILED TO OPEN DISTALLY. A THIRD PIPELINE WAS USED TO FULLY OPEN THE FIRST PIPELINE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PIPELINE (PLI-20) WAS IMPLANTED BUT WAS NOT FULLY APPOSED TO THE DISTAL PORTION OF THE LANDING ZONE. A SECOND PIPELINE (PLI-10) WAS USED IN AN ATTEMPT TO OPEN THE FIRST PIPELINE, BUT THIS SECOND PIPELINE WOULD NOT FULLY OPEN IN THE DISTAL SEGMENT. THE PIPELINE WAS REMOVED WITHOUT INCIDENT AND ANOTHER PIPELINE WAS USED IN ITS PLACE. IT WAS NOTED THE MIDDLE SECTION OF THE PIPELINE WAS POSITIONED IN A BEND, MORE THAN 50% WAS DEPLOYED, AND RESHEATHING WAS DONE MORE THAN TWICE. 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 ANGIOGRAPHIC RESULTS SHOWED GOOD RESULTS AND THE DEVICE WAS OPEN. ANCILL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10532397 ↗
• MalfunctionDec 3, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE WOULD NOT OPEN. PRIOR TO THE EVENT, STANDARD DEPLOYMENT OF THE PIPELINE BEGAN IN THE M1 HORIZONTAL SEGMENT BUT IT WOULD NOT OPEN PAST THE LAST 2MM OF THE PIPELINE. SEVERAL ATTEMPTS WERE MADE TO OPEN THE IN THE STRAIGHT VERTICAL INTERNAL CAROTID ARTERY (ICA), BUT WITHOUT SUCCESS. THE PIPELINE WAS DEPLOYED MORE THAN 50% WHEN IT FAILED TO OPEN. IT WAS RESHEATHED MORE THAN TWO TIMES, BUT THE MIDDLE AND DISTAL SEGMENT STILL WOULD NOT OPEN SO IT WAS REMOVED TOGETHER WITH THE MICROCATHETER. ONCE REMOVED, THE PIPELINE WAS COMPLETELY RESTRAINED AND FINALLY OPENED AFTER THE PHYSICIAN MOVED IT AROUND IN HIS HANDS. THE PROCEDURE WAS COMPLETED WITH IMPLANTATION OF TWO PIPELINES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING OFF LABEL TREATMENT OF DIRECT CAROTID CAVERNOUS FISTULA. THE DISTAL AND PROXIMAL LANDING ZONE WAS 4.51MM X 4.51MM. THE PATIENT¿S VASCULATURE WAS NORMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9407285 ↗

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-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