PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-300-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000284008), received between Apr 30, 2025 and Dec 9, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Retraction Problem; Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT WAS DEPLOYED, RECAPTURING THE DISTAL TIP WITH THE SLEEVES WAS UNUSUALLY DIFFICULT. IT WAS NOTED THAT THE PUSHWIRE/CAPTURE COIL STUCK DURING RETRACTION IN THE LOCATION OF THE PTFE SLEEVES. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, FUSIFORM, RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH A MAX DIA METER OF 7 MM AND A 7 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 1.9 MM DISTALLY AND 3.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS NOT ADMINISTERED. THE ANGIOGRAPHIC RESULT POST P ROCEDURE SHOWED THE IMPLANTED DEVICE LOOKED FINE; THE CASE WENT VERY WELL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (RIGHT MCA; OFF-LABEL). THE PUSHWIRE WAS ROTATED DURING REMOVAL. THE PUSHWIRE AND CATHETER WERE NOT DAMAGED. THE CAPTURE COIL WAS NOT DAMAGED DURING REMOVAL. THE ANCILLARY DEVICES INCLUDED A PHENOM 27 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756744 ↗
• MalfunctionJun 30, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.9MM AND THE NECK DIAMETER WAS 2.1MM. VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED FOR 5 DAYS PRIOR TO SURGERY. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER DELI VERING AND ANCHORING THE SYSTEM, DEPLOYMENT BEGAN AT THE M2 SEGMENT UNDER FLUOROSCOPIC OBSERVATION. IT WAS OBSERVED THAT THE OPENING WAS ABNORMAL; THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE Y-VALVE WAS LOCKED AND PUSH/PULL WAS REPEATED, BUT STENT OPENING DID NOT IMPROVE. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THANK 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. THE PIPELINE WAS REMOVED AND REPLACED WITH A SLIGHTLY LARGER PIPELINE SHIELD (MODEL: PED2-300-25) WHICH WAS DELIVERED AND ADHERED WELL DURING DEPLOYMENT, CONFIRMED UNDER FLUOROSCOPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22364839 ↗
• MalfunctionApr 30, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO DEPLOY FROM THE SHEATH DURING THE PROCEDURE. THE FAILURE DID NOT CAUSE HARM TO THE EMPLOYEE OR PATIENT. NO ADVERSE OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21936325 ↗

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-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-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