Pipeline PED-425-20 (UDI 00836462015487)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00836462015487), received between Oct 7, 2019 and Jan 22, 2020 — classified as 2 injuries.

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.

• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT POST-OP, THE PATIENT EXPERIENCED AN ASYMPTOMATIC STROKE/CEREBRAL INFARCTION, DISTAL EMBOLISM AT THE TARGET BLOOD VESSEL AREA. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, LEFT C4 PARACLINOID/PARASELLAR ANEURYSM WITH A MAX DIAMETER OF 10.0 MM AND A 6.8 MM NECK DIAMETER. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ASYMPTOMATIC STROKE/CEREBRAL INFARCTION, DISTAL EMBOLISM AT THE TARGET BLOOD VESSEL AREA. IT WAS NOTED AS NOT SERIOUS AND THE PATIENT RECOVERED WITH A CONFIRMATION DATE OF (B)(6) 2018. TREATMENT INCLUDED ASPIRIN AND C LOPIDOGREL. A CAUSAL RELATIONSHIP WITH THE EQUIPMENT/PROCEDURE COULD NOT BE DENIED.

  Patient problems: Embolus; Infarction, Cerebral

  MAUDE report 9616736 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THERE WAS TOTAL OCCLUSION INSIDE THE PIPELINE AFTER IT WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS NO MALFUNCTION OF THE PIPELINE. THE PIPELINE WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE CAUSE WAS UNKNOWN OF OCCLUSION (AFTER IMPLANTATION, THERE WAS NO PROBLEM IN TAKING MEDICATION, THUS IT WAS UNKNOWN THAT WHAT WAS THE CAUSE). THERE WAS NOT IN-STENT STENOSIS. THOUGH IT DEVELOPED ACUTE THROMBUS OCCLUSION, CURRENTLY COLLECTING THERAPY WAS PERFORMED AND THE PATIENT HAD A GOOD CLINICAL COURSE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A GIANT UNRUPTURED SACCULAR AORTIC ANEURYSM MEASURING 15-20CM. THE DISTAL AND PROXIMAL LANDING ZONE AROUND C3 OF THE INTERNAL CAROTID ARTERY. 3 MONTHS AFTER TREATMENT, THERE WAS THROMBUS OCCLUSION. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY.

  Patient problems: Thrombosis

  MAUDE report 9164075 ↗

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-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-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-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