PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-250-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000283889), received between Apr 28, 2025 and Jul 9, 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 9, 2025Structural Problem; Activation, Positioning or Separation Problem; Structural Problem; Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER MEASUREMENT, THE SURGEON SELECTED PED2-250-20 AND DEPLOYED IT SMOOTHLY. WHEN THE SURGEON WANTED TO PERFORM GUIDEWIRE, THE PROXIMAL SEGMENT OF THE DENSE MESH SHORTENED TO THE ANEURYSM. THE SURGEON IMMEDIATELY REPLACED IT WITH PED2-300-20 AND COMPLETED THE OPERATION SMOOTHLY AND SAFELY. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED MIDDLE BIFURCATION. ANEURYSM WITH A MAX DIAMETER OF 10 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5MM DISTAL, 4.5 MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS THE BLOOD VESSELS WERE THIN, WHICH WAS A SACCULAR ANEURYSM.

  Patient problems: Failure of Implant

  MAUDE report 22459706 ↗
• MalfunctionApr 28, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WITH SHIELD STENT FAILED TO OPEN AT THE TIP DURING DEPLOYMENT. THE PIPELINE THEN GOT STUCK IN THE PHENOM 27 MICROCATHETER DURING RETRIEVAL. IT WAS NOTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BOTH DEVICES WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT UNRUPTURED ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE ANEURYSM NECK DIAMETER WAS ALSO 3MM. VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. POST PROCEDURE ANGIOGRAPHY SHOWED THE ANEURYSM WITH PROXIMAL ANEURYSM STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919661 ↗

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-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