PIPELINE PED-425-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536016262), received between Dec 12, 2018 and Jan 19, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 16, 2026.

Recalls naming this device

1. Jul 13, 2021Open, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2022Unintended Movement; Activation Failure; Unintended Movement; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY AND THE MARKSMAN CATHETER WAS DAMAGED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY. THE MAX DIAMETER WAS 15MM, AND THE NECK DIAMETER WAS 9MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.9MM DISTAL AND 4.25MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT THE HEAD SEGMENT OF THE PIPELINE COULD NOT BE OPENED. REPEATED ADJUSTMENTS AND TROUBLE-SHOOTING DID NOT RESULT THE ISSUE. THE PIPELINE FELL INTO THE TUMOR. IT WAS NOTICED THAT THE HEAD SEGMENT OF THE MARKSMAN WAS SEVERELY DAMAGED. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289761 ↗
• InjuryApr 8, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO MEDICAL INTERVENTION REQUIRED TO TREAT THE PATIENT'S DROP IN BLOOD PRESSURE. T HERE WAS NO ADDITIONAL SURGERY SCHEDULED OR PLANNED TO COMPLETE TREATMENT OF THE PATIENT'S ANEURYSM. IT WAS CLARIFIED THAT THE PIPELINE PUSHWIRE DID NOT ACTUALLY SEPARATE OR BREAK. THE PATIENT WAS RECOVERING FROM THE PROCEDURE WITH ASSISTANCE OF MEDICATION.

  Patient problems: Low Blood Pressure/ Hypotension; Stenosis

  MAUDE report 11636730 ↗
• MalfunctionMar 4, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX DISTAL SECTION DID NOT OPEN. UPON REMOVAL OF THE DEVICES, THE TIP OF THE MARKSMAN CATHETER WAS NOTED TO BE DAMAGED AND KINKED. THIS EVENT OCCURRED IN THE INTERNAL CAROTID ARTERY (ICA). THE ICA ANEURYSM WAS UNRUPTURED, AND AMORPHOUS. THE MAX DIAMETER WAS 4.5 MM AND THE NECK WAS 4.5 MM. THE DISTAL LANDING ZONE WAS 3.5 MM AND THE PROXIMAL WAS 4.5 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED. POST THE INTERVENTION, THE ANGIOGRAPHIC RESULTS WERE GOOD. A NEW PIPELINE DEVICE WAS USED TO TREAT THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9788566 ↗
• MalfunctionMay 14, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN WHEN ATTEMPTING TO DEPLOY, EVEN AFTER 2 ATTEMPTS WERE MADE. AS A RESULT THE DEVICE WAS REPLACED WHICH OPENED FINE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, FUSIFORM CAVERNOUS ICA WITH A MAX DIAMETER OF 1.2CM AND NO NECK DUE TO FUSIFORM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED WHICH SHOWED A PRU LEVEL OF 100. POST PROCEDURE ANGIOGRAPHIC RESULTS WERE VERY GOOD. THE DEVICES WERE PREPARED PER THE IFU. THE PIPELINE WAS NOT PLACED IN A BEND, LESS THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8609882 ↗
• MalfunctionDec 12, 2018Activation Failure; Activation Failure

  THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED PER THE IFU. THE INNER DIAMETER OF THE HEADWAY-27 WAS 0.027".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156896 ↗

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-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