Pipeline PED-425-25 (UDI 00836462015821)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015821), received between Oct 30, 2019 and Dec 23, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

12 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL SECTION OF THE PIPELINE FLEX DEVICE OPENED WELL. THEREFORE, THE PHYSICIAN DECIDED TO CONTINUE THE DEPLOYMENT ACROSS THE NECK OF THE ANEURYSM. HOWEVER, THE DEVICE DID NOT OPEN, PHYSICIAN RE-SHEATHED AND ANOTHER ATTEMPT TO OPEN IT WAS MADE, BUT STILL THE DEVICE DID NOT OPEN. THE PHYSICIAN DECIDED TO REMOVE THE PIPELINE FLEX AND USED A NEW PIPELINE TO TREAT THE PATIENT. THE PIPELINE FLEX AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE PROXIMAL SECTION FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT VERTEBRAL ARTERY, SACCULAR, UNRUPTURED ANEURYSM. THE MAX DIAMETER WAS 14MM AND THE NECK WAS 4MM. THE DISTAL LANDING ZONE WAS 3.4MM AND THE PROXIMAL3.9MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511020 ↗
• MalfunctionOct 30, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PROXIMAL SECTION OF THE PIPELINE FLEX TWISTED DURING DEPLOYMENT IN A SHARP BEND IN THE CAVERNOUS TERRITORY. MORE THAN 50% OF THE DEVICE WAS DEPLOYED WHEN THE EVENT OCCURRED. THE DEVICE WAS RESHEATHED LESS THAN 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICE. THE DEVICE WAS REMOVED WITH THE CATHETER. COMPETITOR DEVICES WERE USED TO TREAT THE PATIENT. THIS EVENT OCCURRED DURING THE TREATMENT OF AN INTERNAL CAROTID ARTERY, BLISTERING, RUPTURED ANEURYSM, THAT WAS AMORPHOUS. THE MAX DIAMETER 0.8MM AND NECK DIAMETER OF 1MM. THE DISTAL LANDING ZONE WAS 3.8MM AND THE PROXIMAL END WAS 4.2MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9258324 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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-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