PIPELINE PED-250-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536014404), received between Oct 30, 2020 and Oct 21, 2021 — classified as 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND WHEN THE FAILURE TO OPEN OCCURRED. REPEATED RECOVERY WAS DONE WITH DEPLOYMENT IN SITU BUT THE PIPELINE FAILED TO OPEN AND THE PIPELINE WAS REMOVED. AFTER THE REPLACEMENT PIPELINE WAS IMPLANTED, THE CONTRAST WAS RETAINED IN THE ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674120 ↗
• InjuryJun 21, 2021Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NOT CATHETER KICKBACK. THE CAUSE OF THE PIPELINE MOVEMENT DURING DEPLOYMENT WAS D DETERMINED TO BE DUE TO THE PATIENT'S ANATOMY.

  Patient problems: Headache; Intracranial Hemorrhage

  MAUDE report 12036964 ↗
• MalfunctionJan 27, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11234876 ↗
• MalfunctionOct 30, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MARKSMAN MICROCATHETER WAS PLACED AT THE TARGET SITE, AND THE PIPELINE WAS DEPLOYED. HOWEVER, IT WAS FOUND THAT AFTER THE TIP WAS DEPLOYED 10 MM IN LENGTH, IT COULD NOT BE OPENED. REPEATED ATTEMPTS WERE PERFORMED, BUT THE STENT STILL DID NOT OPEN. ANOTHER 6 MM OF THE STENT WAS DEPLOYED, BUT THE ISSUE WAS STILL NOT RESOLVED. IT WAS DECIDED TO WITHDRAW THE ENTIRE SYSTEM, AND REPLACEMENT PRODUCTS WERE USED WITH NO ISSUE. 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 POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 5.8 MM AND A 3.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS UNKNOWN.

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

  MAUDE report 10763719 ↗

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-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