PIPELINE PED-250-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536014343), received between Sep 1, 2022 and Sep 1, 2022 — classified as 1 injury.

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 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A PIPELINE FLEX IMPLANTED IN AN ARTERY BEHIND THE PATIENT'S EYE TO ADDRESS AN ANEURYSM. THE CALLER MENTIONED IT TOOK THE PHYSICIAN 8 TRIES TO IMPLANT THE PRODUCT AND THIS CLOSED THE PATIENT'S MAIN ARTERY LEADING TO THEIR BRAIN. THE PHYSICIAN EXPLAINED WHAT HAPPENED TO THE PATIENT 3 DAYS POST IMPLANT, THAT THE ARTERY CLOSED, AND 3 DAYS FOLLOWING THAT A HOSPITAL SPOKESPERSON EXPLAINED THE PATIENT HAD A BLOOD CLOT THEN A STROKE. THE PHYSICIAN LATER SAID NO, THE ARTERY CLOSED. THE PATIENT WAS DISCHARGED AFTER A DELAYED PROCESS TO LEAVE FACILITY AND LONG TRANSPORT TO LONG TERM CARE, LATER THAT NIGHT THE PATIENT HAD A "CODE BLUE" AND SUFFERED A MASSIVE STROKE THEN SPENT 1 MONTH IN A NEURO ICU RECOVERING. THE CALLER'S ORIGINAL QUESTION ABOUT MRI SAFETY WAS DUE TO THE PATIENT HAVING FREQUENT VOMITING OVER THE LAST 2 MONTHS AND LOSING 25 POUNDS OF BODY WEIGHT. THE MRI WAS TO HELP DETERMINE WHAT MIGHT BE CAUSING THE FREQUENT VOMITING.

  Patient problems: Nausea; Obstruction/Occlusion; Stroke/CVA; Thromboembolism

  MAUDE report 15341081 ↗

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