Pipeline TM Flex Embolization Device with Shield Technology TM PED2-500-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000449599), received between Jan 20, 2026 and Mar 23, 2026 — 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 18, 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.

• MalfunctionMar 23, 2026Difficult to Remove; Retraction Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF A AXIUM COIL THAT WAS DAMAGED/PREMATURE DETACHMENT AND NON-DETACHMENT. PIPELINE THAT BECAME STUCK IN THE PHENOM27 AND CAPTURE COIL AND HAD RESISTANCE DURING DELIVERY AND RETRACTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A LEFT VERTEBRAL ARTERY VESSEL RUPTURE WITH A MAXIMUM DIAMETER OF 9MM, NECK DIAMETER OF 3MM, A LANDING ZONE (ARTERY SIZE) OR 5MM DISTAL AND 5MM PROXIMAL. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT )WAS ADMINISTERED WITH A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 160. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS ADEQUATE OCCLUSION OF RUPTURED LEFT VERTEBRAL USING AXIUM COILS AND PIPELINE FLEX EMBOLIZATION DEVICE. IT WAS REPORTED THAT A PATIENT HAD EXTREMELY TORTUOUS LEFT VERTEBRAL ARTERY CAUSING A "CRIMPED" DISTAL END TO THE 6 FR SOFIA GUIDE PLACED INTO THE DISTAL LEFT VERTEBRAL ARTERY FROM THE COOK SHUTTLE IN THE LEFT SUBCLAVIAN PROVIDING REDUCED SUPPORT AND TRACKABILITY OF THE PLATO MICROCATHETER INTO THE SITE OF RUPTURE IN LEFT VERTEBRAL TO BE COILED WITH AXIUM COILS. DELIVERY OF AXIUM COILS A MIX OF BOTH AXIUM PRIME FRAME AND AXIUM SS COILS. UPON DEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670205 ↗
• MalfunctionJan 20, 2026Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117530 ↗

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-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-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-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