PIPELINE PED-350-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536015333), received between Oct 19, 2021 and Oct 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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, 2021Class IOpen, 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.

• MalfunctionOct 19, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AND THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR EMBOLIZATION TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM-CAVERNOUS IN THE SINUS SEGMENT WITH A MAX DIAMETER OF 12MM AND A 8MM NECK DIAMETER. THE LANDING ZONE WAS 3.14MM AT THE DISTAL END AND 3.35MM AT THE PROXIMAL END. THE ACCESS VESSEL WAS 8F WITH A DIAMETER OF 20MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT PED IMPLANTATION WAS REQUIRED FOR ANEURYSM EMBOLIZATION. THE PATIENT¿S PATH WAS MODERATELY TORTUOUS, AND A PHENOM27 CATHETER WAS USED TO DELIVER A 3.5*16 PED STENT. AFTER THE MICROCATHETER WAS IN PLACE, THE PED WAS DELIVERED. THE DISTAL END COULD NOT BE PUSHED (FAILURE TO OPEN), AND THE RESISTANCE WAS LARGE IN THE DISTAL SECTION, AND IT COULD NOT PASS THROUGH REPEATED ATTEMPTS. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. RE-REPLACEMENT WAS GIVEN WITHOUT CAUSING PERSONAL INJURY AS IT WAS REMOVED WITH THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657243 ↗

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-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