Pipeline PED-450-35 (UDI 00836462015876)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015876), received between Jan 6, 2020 and Jul 24, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 24, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING THE PROCEDURE THE PIPELINES WERE BEING PLACED IN A VESSEL BEND WHEN THEY FAILED TO OPEN. ATTEMPTS TO OPEN THE DEVICES WERE MADE WITH RESHEATHING AND ATTEMPTING TO OPEN IN OTHER VESSELS BUT ATTEMPTS WERE STILL UNSUCCESSFUL. THE PROCEDURE COULD NOT BE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10319987 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT PIPELINE FLEX DEVICE WAS INTENDED TO BE DELIVERED FROM THE M1 INTO THE ICA, BUT THE DEPLOYED THE DEVICE INTO A BRANCH OFF OF THE M1. THE DEVICE WAS PLACED, AND THE CASES ENDED. 1 HR LATER THE PATIENT WAS BROUGHT BACK TO THE LAB WITH A THROMBUS DISTAL TO ADJACENT. THE PATIENT WAS GIVEN INTEGRILLIN AND IS STILL ON INTEGRILLIN DRIP. THE PIPELINE DEVICE COVERED THE ANEURYSM BUT JAILED OFF THE M1-M2. VERY SLUGGISH FLOW AND WAS PUT ON INTEGRILLIN DRIP AND TRANSFERRED TO PATIENT¿S ROOM. THE PATIENT IS CURRENTLY DOING WELL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES: 6FR SHUTTLE, NAVINE 058 115, PHENOM 027, ASAHI 10. THIS EVENT OCCURRED DURING THE TREATMENT OF A SUPRACLINOID, RIGHT, SACCULAR ICA ANEURYSM. THE MAX DIAMETER WAS 18MM AND THE NECK WAS 8MM. THE DISTAL LANDING ZONE WAS 2MM AND THE PROXIMAL WAS 4.5MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: Thrombosis

  MAUDE report 9555215 ↗

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-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-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-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-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