PIPELINE PED-300-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536014824), received between Sep 8, 2020 and Apr 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE PIPELINE STENT HAD POOR OPENING OF THE TIP. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS WERE NORMAL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 4.6 MM AND A 3.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618978 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE BECAME STUCK AT THE DISTAL END OF THE MARKSMAN MICROCATHETER, AND A SECOND PIPELINE HAD THE PUSHWIRE BREAK. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE M1M2 JUNCTION IN THE MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, BUT THE PRU LEVEL WAS NONE. IT WAS REPORTED THAT THERE WAS RESISTANCE IN THE DISTAL SEGMENT OF THE MARKSMAN MICROCATHETER AND THE FIRST PIPELINE (PLI-10). THE DISTAL SECTION OF THE CATHETER WAS ACCORDIONED AND ADHERED TO THE STENT WHICH PREVENTED THE PIPELINE FROM BEING DELIVERED AND DEPLOYED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THE PHYSICIAN RELEASED THE LOAD BUT THE ISSUE DID NOT RESOLVE. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE, AND THE DEVICE WAS REMOVED. REPLACEMENT DEVICES WERE USED, BUT THE SECOND PIPELINE (PLI-20) EXPERIENCED A PUSHWIRE BREAK AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE CATHETER WAS USED TO RETRIEVE THE BROKEN SEGMENTS OF THE PUSHWIRE, AND THERE WAS FRICTION DURING THE RETRIEVAL PROCESS. IT WAS THE STATED REPLACEMENT DEVICES WERE AGAIN USED TO

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

  MAUDE report 10502422 ↗

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-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-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-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