Pipeline PED-475-16 (UDI 00836462015586)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015586), received between Jun 24, 2020 and Dec 8, 2020 — classified as 2 malfunctions.

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.

• MalfunctionDec 8, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN DISTALLY AND EXPERIENCED RESISTANCE IN THE DISTAL SEGMENT OF THE PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, WIDE-NECKED, SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 7 MM, AND THE NECK DIAMETER WAS 4 MM. THE LANDING ZONE WAS 4.53 MM DISTAL AND 4.78 MM PROXIMAL. THE PATIENT¿S VESSEL TORTUOSITY WAS SEVERE AND WAS SAID TO HAVE A HIGH RIDING POSTERIOR GENU. THE ACCESS VESSEL WAS THE ICA AND WAS 4.78 MM IN DIAMETER. IT WAS REPORTED THAT THE PHENOM 27 MICROCATHETER WAS ADVANCE INTO THE M1 WITH A DEGREE OF DIFFICULTY. THE FIRST PIPELINE (4.5 X 20) WAS ATTEMPTED TO BE ADVANCE PAST THE ANEURYSM. THE PHYSICIAN EXPERIENCED A GREAT DEGREE OF RESISTANCE AND EVENTUALLY NAVIGATED INTO POSITION AND BEGAN TO UNSHEATHE THE DEVICE. APPROXIMATELY 50% OF THE DEVICE WAS UNSHEATHED AND THE DISTAL TINES OF THE PIPELINE WOULD NOT OPEN AND APPEARED TO BE FRAYED. THE DEVICE WAS REMOVED,AND A SECOND ATTEMPT WAS MADE WITH A 4.75 X 18 PIPELINE. THE PHYSICIAN ENCOUNTERED RESISTANCE AND ONCE IN POSITION AGAIN ATTEMPTED TO DEPLOY THE DEVICE. THE PIPELINE AGAIN OPENED IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972793 ↗
• MalfunctionJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DELIVERY SYSTEM BROKE OFF AT RE-SHEATHING PAD. IT WAS REPORTED THAT AFTER PIPELINE FLEX WAS DEPLOYED, THE PHYSICIAN ATTEMPTED TO RECAPTURE DELIVERY SYSTEM IN STRAIGHT M1 SEGMENT, MET SIGNIFICANT RESISTANCE, STOPPED AND PULLED IT AND MICROCATHETER OUT. UPON INSPECTION ON BACK TABLE, DELIVERY SYSTEM BROKE OFF AT RE-SHEATHING PAD. THE DEVICE OPEN AND PLACED WHERE PHYSICIAN INTENDED. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE PRU LEVEL WAS IN NORMAL RANGE. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR PARA OPHTHALMIC ANEURYSM, MEASURING 10MMX6MM, LANDING ZONE DISTAL 4.0MM, PROXIMAL 4.8MM. THE VESSEL OBSERVED NORMAL TORTUOUS. NO PATIENT INJURY WAS REPORTED. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10190735 ↗

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-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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