Pipeline TM Flex Embolization Device with Shield Technology TM PED2-475-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000449476), received between Mar 11, 2026 and Sep 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Material Frayed; Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735981 ↗
• MalfunctionApr 20, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT COULD NOT BE OPENED IN THE MIDDLE AND POSTERIOR SEGMENT. ADDITIONALLY, A PHENOM 27 MICROCATHETER WAS DIFFICULT TO NAVIGATE IN TORTUOUS ANATOMY. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.5 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.5 MM DISTALLY AND 4.9 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 4.7 MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED A LEFT C6 SEGMENT ANEURYSM. IT WAS REPORTED THAT BECAUSE THE LESION WAS LOCATED AT A LEFT INTERNAL CAROTID ARTERY C6 ANEURYSM AND THE VESSEL ANATOMY WAS SEVERELY TORTUOUS, THE PHENOM 27 MICROCATHETER, UNDER NEURO GUIDEWIRE GUIDANCE, WAS ABLE TO BARELY BE GUIDED INTO THE DISTAL MIDDLE CEREBRAL ARTERY AFTER SEVERAL ATTEMPTS TO PERFORM DEPLOYMENT. THE TIP OPENING OF THE STENT OPENED. THE PHENOM 27 MICROCATHETER WAS THEN RETRACTED TO APPROXIMATEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927661 ↗
• MalfunctionMar 31, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT OF A PIPELINE THAT FAILURE TO OPEN ON THE DISTAL END OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT CAROTID ARTERY WITH A MAX D IAMETER OF 4MM AND A 5MM NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 4MM DISTAL AND 4.5MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS AN INTRACRANIAL ANEURYSM. IT WAS REPORTED THAT AFTER ESTABLISHING ACCESS, THE STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER EXPOSING APPROXIMATELY 7¿8 MM OF THE DISTAL END OF THE STENT AND WAITING FOR ABOUT 10 SECONDS, THE DISTAL END DID NOT OPEN. THE STENT WAS FURTHER DEPLOYED BY APPROXIMATELY 12 MM; HOWEVER, THE DISTAL END STILL FAILED TO OPEN. THE OPERATOR ATTEMPTED RESHEATHING AND REDEPLOYMENT, AS WELL AS MANIPULATION INCLUDING SHAKING AND PUSHING/PULLING, BUT THE DISTAL END REMAINED UNOPENED. ADJUSTMENTS TO THE MICROCATHETER TENSION WERE ALSO ATTEMPTED WITHOUT SUCCESS. THE STENT WAS THEN WITHDRAWN FROM THE BODY. UPON INSPECTION, THE DISTAL END OF THE STENT WAS FOUND TO BE UNABLE TO OPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741599 ↗
• MalfunctionMar 11, 2026Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF A LEFT C5 UNRUPTURED AMORPHOUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS WAS 10MM AND THE NECK DIAMETER WAS 11MM. PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS NOT ADMINISTERED. IT WAS REPORTED THAT THE PIPELINE DEVICE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT, THE DISTAL TIP OF THE PIPELINE STENT FAILED TO OPEN. IT WAS NOTED THAT LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES. THE SURGEON ATTEMPTED DEPLOYMENT USING PUSH-PULL-RELEASE TECHNIQUE BUT THE PIPELINE STILL FAILED TO OPEN. THE STENT WAS RETRIEVED AND DEPLOYED AGAIN AND GIVEN TIME TO OPEN BUT WITHOUT SUCCESS. THE PIPELINE WAS THEN RETRIEVED FROM THE PATIENT'S BODY AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574663 ↗
• MalfunctionMar 11, 2026Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN AND FRAYING WERE IDENTIFIED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568323 ↗

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-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-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-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-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