Pipeline PED-450-20 (UDI 00836462015548)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015548), received between Jan 10, 2020 and Jul 16, 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.

• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT A PATIENT EXPERIENCED MASS EFFECT AFTER PIPELINE FLEX IMPLANTATION. THE PATIENT UNDERWENT PIPELINE FLEX IMPLANTATION IN THE TREATMENT OF A CAVERNOUS, LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE ANEURYSM MAX. DIAMETER WAS 22.4 MM AND NECK WIDTH WAS 8.9 MM. THERE WERE NO REPORTS OF ANY DEVICE ISSUES DURING IMPLANTATION. ONE DAY POST-INTERVENTION, MRI IMAGE SHOWED WORSENING MASS EFFECT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT IS REPORTEDLY FINE. THERE WAS NO REPORT OF ANY NEUROLOGICAL SYMPTOMS AS A RESULT OF THIS EVENT. THE PHYSICIAN REPORTS THE ISSUE WAS NOT RELATED TO THE INTERVENTION OR TO THE USE OF PIPELINE. THE PATIENT REPORTEDLY DID NOT HAVE MASS EFFECT PRIOR TO THE PROCEDURE. PRIOR TO INTERVENTION, THE PATIENT¿S MRS WAS 0. POST-INTERVENTION, MRS WAS 1. THERE WAS CAUSAL RELATIONSHIP WITH EQUIPMENT AND THE MASS EFFECT DETERIORATION. SEVERITY: NOT SERIOUS. OUTCOME: RECOVERY, OUTCOME CONFIRMATION DATE: MARCH 9, 2017.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 10283907 ↗
• MalfunctionJan 10, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DUE TO MANIPULATION BY THE HEALTHCARE PROVIDER (HCP). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 9MM AND A 4MM NECK DIAMETER, AND A LANDING ZONE OF 3.8X4.1MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PIPELINE APPEARED TO BE TWISTED AFTER BEING OVERWORKED BY THE HEALTHCARE PROVIDER (HCP) BEING PROCTORED BY THE MAIN PHYSICIAN OVERSEEING THEM. AS A RESULT, THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION, BUT MORE THAN 50% HAD BEEN DEPLOYED. IT WAS NOTED THE PIPELINE WAS IN A PROXIMAL PART OF A BEND. THE DEVICE WAS RE-SHEATHED LESS THAN OR EQUAL TO TWO TIMES, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. THE DEVICE WAS RE-SHEATHED, AND REMOVED FROM THE PATIENT. A NEW PIPELINE WAS INTRODUCED AND DEPLOYED WITH NO ISSUE TO COMPLETE THE PROCEDURE. AFTER THE CASE, THE MAIN PHYSICIAN STATED THAT IT WAS NOT A DEVICE PROBLEM AND THAT IT SHOULD NOT HAVE BEEN MANIPULATED THE WAY IT WAS AND IT WOULD NOT HAVE BEEN AN ISSUE. ANGIOGRAPHIC RESULTS POST-PROCEDURE WERE GOOD. IT WAS INDICATED THAT ALL DEVICE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9575709 ↗

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-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-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-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