PIPELINE PED-450-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536016323), received between Sep 29, 2021 and Sep 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Ejection” (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.

• MalfunctionSep 29, 2021Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED A REPORT THAT THE ONE PIPELINE EXPERIENCED RESISTANCE IN THE HUB OF THE PHENOM 27 MICROCATHETER, TWO PIPELINES DEPLOYED IN THE CATHETER HUB, AND A THIRD FAILED TO OPEN DISTALLY AND BROKE DURING RETRIEVAL. THE PATIENT WAS UNDERGOING FLOW DIVERSION TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 2.9MM, AND THE NECK DIAMETER WAS 1.5MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.5MM DISTAL AND 4.5MM PROXIMAL. THE ACCESS VESSEL WAS THE LEFT ICA, WHICH WAS 3.5-4.5MM IN DIAMETER. IT WAS REPORTED THAT THE FIRST PIPELINE WAS INSERTED INTO THE FIRST PHENOM 27 CATHETER AND DEPLOYED IN THE HUB DURING INSERTION. THE DEVICE WAS REMOVED. A SECOND PIPELINE WAS INSERTED INTO THE CATHETER WITH EXTRA PRECAUTION. THIS DEVICE HAD RESISTANCE IN THE CATHETER HUB AND ALSO DEPLOYED IN HUB. THE TIP OF THE SHEATH HAD BEEN SEATED SECURELY IN THE HUB. THE SECOND PIPELINE WAS REMOVED ALONG WITH PHENOM 27 CATHETER WHICH WAS REPLACED WITH A NEW PHENOM 27. A THIRD PIPELINE WAS INSERTED INTO THE CATHETER AND WAS ABLE TO BE INTRODUCED INTO CATHETER. DURING DEPLOYMENT OF THIS PIPELINE, THE DEVICE WOULD NOT OPEN DISTALLY AND HAD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550138 ↗

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-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-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-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