PIPELINE PED-350-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536015456), received between Jul 1, 2020 and Sep 25, 2023 — 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.

• MalfunctionSep 25, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE MARKSMAN WAS USED TO DELIVER THE PIPELINE, THE PIPELINE COULD NOT BE PUSHED IN THE MIDDLE SEGMENT OF THE MARKSMAN. THE PIPELINE COULD NOT BE PUSHED DESPITE REPEATED ATTEMPTS. THE PIPELINE FAILED TO OPEN AT THE DISTAL END. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 11MM AND A 5.3MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 2.77MM DISTALLY AND 3.38MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 20F. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.   ANCILLARY DEVICES INCLUDE A JOHNSON JOHNSON SHEATH, JOHNSON JOHNSON GUIDE CATHETER, AND A SY-2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807562 ↗
• MalfunctionJul 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IMPLANT WAS ATTEMPTED REPEATEDLY, HOWEVER, THE DENSE MESH STENT COULD NOT BE PUSHED FROM THE SHAPEABLE MICROCATHETER IN THE PATIENT'S BODY. IT WAS THOUGHT TO BE A PROBLEM WITH THE PRODUCT QUALITY THAT LED TO THIS ISSUE. THE NAVIEN WAS REPLACED AND THE PRODUCT COULD BE DELIVERED NORMALLY. THE RESISTANCE IN THE CATHETER WAS IN THE MIDDLE SECTION. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH A HEPARINIZED SALINE. IT WAS UNKNOWN IF THE CATHETER OR PUSHWIRE WERE DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SLOWED DOWN BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: SHORT SHEATH AND A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15078470 ↗
• MalfunctionJul 1, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EMBOLIZATION DEVICE FAILED TO OPEN IN THE DISTAL SECTION. IT WAS REPORTED THAT WHEN THE PIPELINE WAS ATTEMPTED TO BE DEPLOYED AT THE PREDETERMINED LOCATION IT WOULD NOT OPEN IN THE DISTAL SECTION. THE PHYSICIAN WAITED MORE THAN 10 MINUTES AS ACCORDING TO THE INSTRUCTIONS AND RETRIEVED AND RE-DEPLOYED MORE THAN 2 TIMES, BUT THE PIPELINE STILL COULD NOT BE OPENED. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, AND THE DEVICE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS REMOVED WITH THE MICROCATHETER AND WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE BLOOD FLOW DIVERSION EFFECT WAS SATISFACTORY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 10.18 MM. THE NECK DIAMETER WAS 6.22 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER AND A NAVIEN CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221917 ↗

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-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-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-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-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