PIPELINE PED-375-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536015609), received between May 24, 2019 and Nov 20, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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. How this data works · Data updated Oct 13, 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 · 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.

• MalfunctionNov 20, 2020Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10878223 ↗
• MalfunctionDec 26, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT WHEN THE STENT WAS OPENED AND HYDRATION, IT WAS FOUND THAT THE PUSH GUIDE WIRE WAS BENT AND BROKEN. THE DEVICE WAS NOT USED TO TREAT THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519384 ↗
• MalfunctionJun 2, 2019Unintended Ejection; Activation Failure; Physical Resistance/Sticking; Unintended Ejection; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT AS THE PIPELINE WAS BEING DEPLOYED, IT WAS ATTEMPTED TO PACK THE PIPELINE AT THE NECK AND IT APPEARED TO TWIST. THE DEVICE WAS ATTEMPTED TO BE RESHEATHED AND THE PIPELINE SEPARATED FROM THE RESHEATHING SILICON PAD AND DEPLOYED ITSELF HALF IN THE CATHETER. THE PIPELINE WAS REPORTED TO HAVE BEEN IMPLANTED. NO PATIENT INJURY OCCURRED. THE PIPELINE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT INTERNAL CAROTID ARTERY, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 10MM WITH A NECK WIDTH OF 4MM. THE LANDING ZONE WAS 3.3MM DISTALLY AND 3.75MM PROXIMALLY. THE ANATOMY WAS MODERATE IN TORTUOSITY. IT WAS NOTED THAT THE PHYSICIAN WANTED TO RESHEATH THE PIPELINE DUE TO IT BEING TWISTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8661367 ↗
• MalfunctionMay 24, 2019Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF INTRAPROCEDURAL ANEURYSM RUPTURE DURING PIPELINE FLEX IMPLANTATION. PATIENT PRESENTED WITH A BLISTER ANEURYSM ON THE OPPOSITE WALL OF THE POSTERIOR COMMUNICATING ARTERY OF THE RIGHT ICA. VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE LANDING ZONE ARTERY SIZE WAS 3.24MM DISTAL AND 3.88MM PROXIMAL. IT WAS NOTED THAT THE PHYSICIAN HAD BEEN TRAINED TO PRE-DEPLOY THE PTFE PROTECTIVE SLEEVES ON THE BACK TABLE PRIOR TO DEPLOYMENT AND USED THIS METHOD DURING THIS PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS DEPLOYED IN THE PATIENT AND NOTED TO BE "LAZY" TO FULLY OPEN. A WIRE AND MICROCATHETER WAS NAVIGATED TO EXPAND THE DEVICE, WHICH WAS UNSUCCESSFUL. A BALLOON WAS THEN USED TO OPEN THE PIPELINE FLEX FULLY. AFTER FULLY OPENING, THE PIPELINE FLEX FORESHORTENED -- THE ANEURYSM WAS NOT FULLY COVERED. ULTIMATELY, THREE ADDITIONAL FLOW DIVERSION DEVICES WERE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642755 ↗

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-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-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-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