Pipeline PED-475-35 (UDI 00836462015906)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015906), received between Jun 13, 2019 and Jun 30, 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. 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.

• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAS HAD STENOSIS OF THE PARENT ARTERY FOLLOWING PLACEMENT OF A PIPELINE DEVICE ON (B)(6) 2016; THERE WERE NO DEVICE OR PROCEDURAL ISSUES NOR PATIENT ADVERSE EVENT/SYMPTOMS WERE REPORTED AT TIME OF THE PIPELINE IMPLANTATION SURGERY. THE PATIENT WAS TREATED FOR A SACCULAR ANEURYSM OF THE LEFT C3 CAVERNOUS SINUS. THE ANEURYSM MAX DIAMETER WAS 24.6MM AND THE NECK DIAMETER WAS 7.3MM. THE PATIENT PRESENTED WITH UNSPECIFIED CRANIAL NERVE DISORDER. IT WAS REPORTED THAT TREATMENT DID NOT RESOLVE THE PATIENT'S SYMPTOMS WITH MASS EFFECT (III-VI DISORDER) BEING UNCHANGED AT FOLLOW UP APPOINTMENT ON (B)(6) 2016. STENOSIS THOUGHT TO BE RELATED TO THE PIPELINE STENT FIRST AT 6 MONTH FOLLOW-UP APPOINTMENT ON (B)(6) 2016. THE PATIENT WAS ALSO SEEN (B)(6) 2018 AND (B)(6) 2019 WITH NOTED OPTIC NERVE SYMPTOMS AND MASS EFFECT (III-VI DISORDER) MARKED UNCHANGED PER CLINICIAN REPORT AT EACH FOLLOW-UP VISIT. CORRECTED RANKIN SCALE RATING WAS 1 FOR ALL REPORTED VISITS FROM DATE OF SURGERY TO MOST RECENT. THE PATIENT IS TREATED WITH ASPIRIN AND CLOPIDOGREL.

  Patient problems: Stenosis

  MAUDE report 10214721 ↗
• MalfunctionJun 13, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLOW DIVERTORS FAILED TO EXPAND IN THE MIDDLE SEGMENT. THIS EVENT WAS REPORTED HAVE OCCURRED DURING THE TREATMENT OF INTERNAL CAROTID ARTERY, UNRUPTURED ANEURYSM. THE ANATOMY WAS REPORTED TO HAVE BEEN SEVERE IN VESSEL TORTUOSITY. THE MIDDLE SEGMENT OF THE DEVICE WAS PLACED ON A BEND. BOTH DEVICES WERE DEPLOYED MORE THAN 50% WHEN IT FAILED TO OPEN. THE DEVICES WERE RE-SHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE MADE TO OPEN THE DEVICES AND EACH ONE WAS REMOVED WITH THE CATHETER. A NEW DEVICE WAS SUCCESSFULLY USED TO TREAT THE PATIENT. NO PATIENT INJURY REPORTED. THE DEVICES WERE PREPARED AND USED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8696472 ↗

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-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-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-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