PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000283957), received between Sep 8, 2021 and Jul 31, 2025 — 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.

• MalfunctionJul 31, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE PUSHWIRE BREAK WAS UNDETERMINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22680301 ↗
• MalfunctionSep 8, 2021Unintended Movement; Activation Failure; Physical Resistance/Sticking; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE SHIELD HAD DIFFICULTY UNSHEATHING AND DEPLOYING, RESISTANCE, AND FAILURE TO OPEN. THE PATIENT WAS BEING TREATED FOR A BI-LOBED UNRUPTURED ANEURYSM IN THE M1-M2 LOCATION. THE MAX DIAMETER WAS 3CMX 4 CM. THE NECK DIAMETER WAS 2.3 MM. THE DISTAL LANDING ZONE WAS 3.2 MM AND THE PROXIMAL LANDING ZONE WAS 3.9 MM. VESSEL TORTUOSITY WAS NORMAL.  EXTREME DIFFICULTY UNSHEATHING AND DEPLOYING THE PIPELINE. NORMAL ANATOMY, PREPPED PER INSTRUCTIONS FOR USE (IFU), STANDARD TECHNIQUE USED BY EXPERIENCED PHYSICIAN. AN ABUNDANCE OF RESISTANCE. STUCK (LOCKED UP) IN CATHETER OR RESISTANCE IN CATHETER. THE PIPELINE BECAME STUCK IN THE DISTAL SECTION OF THE CATHETER AND BECAME STUCK DURING DEPLOYMENT. THE PHYSICIAN RELEASED TO LOAD IN THE SYSTEM AND THE ISSUE DID NOT RESOLVE. THE PIPELINE FAILED TO OPEN DISTAL. THE PIPELINE WAS NOT IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS REMOVED WITH THE MICROCATHETER AND THE WAS MOVEMENT DURING PLACEMENT (DIFFICULT PLACEMENT/POSITIONING). MULTIPLE DEVICES WERE NOT BEING USED WHEN MOVEMENT OCCURRED. FRICTION DURING DELIVERY WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442755 ↗

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-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-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