PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000284039), received between Feb 6, 2025 and Feb 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 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.

• MalfunctionFeb 6, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A LARGE PROGRESSIVE DISSECTING ANEURYSM IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY, WHICH WAS FIRST MEASURED AT 13*15MM (ON (B)(6) AND MEASURED 18*23MM DURING SURGERY (ON (B)(6). DURING THE PLANNED OPERATION, THE DENSE MESH STENT WAS ANCHORED IN THE MIDDLE AND DISTAL PART OF THE ANTERIOR A2 TO THE BIFURCATION OF A1 AND CAROTID ARTERY. AFTER THE MICROCATHETER WAS IN PLACE DURING THE OPERATION, THE STENT WAS OPENED AND ANCHORED AND LAID TO THE ANEURYSM NECK. THE POSITION WAS NOT IDEAL, TRIED TO RETRIEVE IT. AFTER THE MICROCATHETER WAS RETRIEVED 20%, THE STENT WAS COMPLETELY IMMOBILE AND COULD NOT BE PUSHED FORWARD OR RETRIEVED. THEY PUSHED THE INTERMEDIATE CATHETER TO GO UPPER TO A1 TO PROVIDE EXTERNAL SUPPORT. THE STENT AND MICROCATHETER WERE LOCKED AND COULD NOT BE PUSHED. AFTER REPEATED ATTEMPTS TO RETRIEVE THE ENTIRE SYSTEM, IT WAS FINALLY REMOVED FROM THE BODY AND THE MICROCATHETER WAS FOUND TO BE SEVERELY DEFORMED (MULTI-SEGMENT FOLDS) IN THE DISTAL SECTION AND THE STENT WAS LOCKED IN THE DISTAL SECTION OF THE CATHETER AND COULD NOT BE REMOVED. THE PHYSICIAN RELEASED THE LOAD IN THE SYSTEM AND IT DID NOT RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21329405 ↗

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-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