PIPELINE PED-375-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536015517), received between Sep 3, 2021 and Sep 3, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2021Break; Positioning Failure; Break; Positioning Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE PUSHWIRE THAT BROKE AFTER DIFFICULTY POSITIONING THE PIPELINE. THE PATIENT WAS UNDERGOING A PROCEDURE TO PIPELINE IMPLANTATION TO TREAT TWO UNRUPTURED ANEURYSMS IN THE LEFT INTERNAL CAROTID ARTERY (ICA), ONE FUSIFORM AND ON AMORPHOUS. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL OF 42. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE (MODEL: PED-375-10, LOT: B158894) WAS DELIVERED AND DEPLOYED. IT WAS RECAPTURED ONCE TO REPOSITION. THEPIPELINE WAS THEN DEPLOYED IN THE CORRECT LOCATION. ONCE DEPLOYED, THE PHENOM MICROCATHETER WAS BROUGHT THROUGH THE PIPELINE TO CAPTURE THE DELIVERY SYSTEM AND THE TIP COIL. HOWEVER, IT WAS DISCOVERED THAT THE DELIVERY SYSTEM, FROM THE TIP COIL TO THE PROXIMAL MARKER, HAD DETACHED FROM THE DELIVERY WIRE. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO SNARE THE PROXIMAL PORTION. SEVERAL ATTEMPTS WERE THEN MADE TO SNARE THE PTFE SLEEVES AND BRING IT THROUGH THE PIPELINE. FINALLY THE TIP COIL WENT THROUGH THE PIPELINE AND INTO THE ICA. THE CORE REMAINED AS A LOOP WITHIN THE DEPLOYED P

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12425231 ↗

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-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-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-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-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