Pipeline PED-350-35 (UDI 00836462015753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462015753), received between Feb 11, 2020 and Feb 11, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT HAD NON-SERIOUS ADVERSE EVENT OF VISUAL PROBLEMS FOUR DAYS POST MEDTRONIC FLOW DIVERTER PROCEDURE. PRIOR TO THE EVENT, THE PATIENT PRESENTED WITH CRANIAL NERVE DISORDER AND HAD PRE-OPERATIVE MASS EFFECT. THERE WERE NO OPTIC NERVE SYMPTOMS AND THE MRS WAS 1. THE PATIENT HAD MEDTRONIC FLOW DIVERTER IMPLANTED SUCCESSFULLY. THERE WERE NO PROBLEMS OR ADVERSE EVENTS DURING THE PROCEDURE. CAUSAL RELATIONSHIP OF DEVICE TO THE ADVERSE EVENT COULD NOT BE DENIED. THERE WAS NO CAUSAL RELATIONSHIP TO THE PROCEDURE. AT 180 DAY FOLLOW UP, THE OPTIC NERVE SYMPTOMS WERE STILL THERE (REMAINED UNCHANGED). MASS EFFECT IMPROVED. MRS WAS 1. ASPIRIN AND CLOPIDOGREL ADMINISTRATION. AT 1 YEAR FOLLOW UP, THE OPTIC NERVE SYMPTOMS WERE STILL THERE (REMAINED UNCHANGED). MASS EFFECT IMPROVED. MRS WAS 1. ASPIRIN AND ADMINISTRATION. AT 2 AND 3 YEAR FOLLOW UP, THE OPTIC NERVE SYMPTOMS WERE STILL THERE (REMAINED UNCHANGED). MASS EFFECT WAS RESOLVED. MRS WAS 1. ASPIRIN AND ADMINISTRATION. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A SACCULAR ANEURYSM MEASURING 27MM X 8MM LOCATED IN THE CAVERNOUS SINUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY (ICA). THE PAT

  Patient problems: Visual Disturbances

  MAUDE report 9691258 ↗

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-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-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-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-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