PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000284640), received between Mar 4, 2024 and Aug 11, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE FLEX WITH SHIELD STENTS THAT FAILED TO OPEN. THE PATIENT, WHO HAD MULTIPLE ANEURYSMS IN THE INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC SEGMENT, WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF A RUPTURED AMORPHOUS ANEURYSM. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS BELOW THE ICA BIFURCATION AND THE PROXIMAL LANDING ZONE WAS IN THE CAVERNOUS SINUS STRAIGHT SEGMENT. PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PIPELINES AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PER THE VESSEL MEASUREMENT, PED2-475-25 WAS SELECTED. THE STENT WAS DELIVERED IN THE M2 AND THE PIPELINE WAS DELIVERED. THE MICROCATHETER WAS WITHDRAWN UNTIL ABOUT 15MM OF THE PIPELINE STENT WAS EXPOSED, BUT THE PIPELINE DID NOT OPEN; THE TIP WAS ROD-SHAPED. THE DEVICE WAS PULLED BACK TO THE ICA AND DEPLOYMENT CONTINUED. THE TIP END WAS ABLE TO BE ANCHORED THEN BUT AT THE BEND OF THE OPHTHALMIC ARTERY, THE STENT AGAIN APPEARED ROD-SHAPED AND COULD NOT BE OPENED DESPITE PUSH AND PULL MANEUVERS. THE PIPELINE WAS REMOVED. A NEW MICROCATHETER WAS THEN USED TO DELI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777635 ↗
• MalfunctionJun 13, 2025Unintended Ejection; Retraction Problem; Material Separation; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Unintended Ejection; Retraction Problem; Material Separation; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING RETRIEVAL THE PIPELINE ENCOUNTERED RESISTANCE IN THE MIDDLE OF THE PHENOM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 4.6MM AND A 9MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.9MM AND PROXIMAL 4.6MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH PRU LEVEL OF 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE PED2-475-25 DENSE MESH STENT WAS PUT TO GO UPPER TO BE IN PLACE THROUGH THE PHENOM27 MICROCATHETER, AND THE STENT WAS DEPLOYED. AFTER THE STENT TIP WAS DEPLOYED, IT WAS IN A FISH MOUTH SHAPE AND NOT FULLY OPENED. AFTER MULTIPLE PUSH AND PULL OPERATIONS, THE PROBLEM COULD NOT BE SOLVED, SO IT WAS DECIDED TO RETRIEVE THE STENT AND DEPLOY THE TIP AGAIN. DURING THE PROCESS OF RETRIEVING THE STENT INTO THE MICROCATHETER, IT WAS OBVIOUSLY FELT THAT THERE WAS A LOT OF RESISTANCE. AFTER IT WAS FULLY RETRIEVED, IT WAS FOUND THAT THE PROXIMAL END OF THE STENT WAS SEPARATED FROM THE RETRIEVE MARK POINT, AND THE PROXIMAL END OF THE STENT WAS DISLODGED, SO IT WAS WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204014 ↗
• MalfunctionMar 31, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE PIPELINE FAILURE WAS NOT DETERMINED (COULDN'T BE OPENED AFTER MULTIPLE ATTEMPTS). THERE WERE NO ISSUE IDENTIFIED WITH THE PHENOM CATHETER USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731122 ↗
• MalfunctionMar 28, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON USED THE SHIELD DENSE MESH STENT TO TREAT THE ANEURYSM OF THE OPHTHALMIC ARTERY SEGMENT OF THE INTERNAL CAROTID ARTERY. THE SIZE OF THE ARTERY WAS ABOUT 14 X 12. THE SURGEON RAISED THE STENT MICROCATHETER PHENOM27 TO THE M2 SEGMENT. AFTER THE STENT WAS DELIVERED TO BE IN PLACE, THE MICROCATHETER WAS WITHDRAWN, EXPOSING THE STENT TIP ABOUT 12MM. THE STENT DID NOT OPEN. THE STENT WAS RETRIEVED AND THE MICROCATHETER WAS WITHDRAWN. AFTER TWO REPETITIONS, THE STENT TIP WAS SLIGHTLY OPENED ABOUT 2MM. THE OPENING WAS NOT IDEAL, AND THE STENT WAS PULLED BACK TO THE NECK, HOPING THAT THE LARGER DIAMETER OF THE INTERNAL CAROTID BLOOD VESSELS WOULD ALLOW THE STENT TO OPEN MORE COMPLETELY. AFTER BEING PULLED BACK TO THE NECK, THE STENT STILL DID NOT OPEN WELL AFTER DEPLOYING ABOUT 15MM IN LENGTH. AFTER BEING RETRIEVED TWICE, THE STENT STILL DID NOT OPEN, SO IT WAS WITHDRAWN FROM THE BODY FOR OBSERVATION. IT WAS FOUND THAT THE STENT WAS PUSHED OUT OF THE MICROCATHETER TIP BY 80%, AND IT WAS STILL ROD-SHAPED. IT WAS REPLACED WITH A NEW STENT AND THE SURGERY CONTINUED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719088 ↗
• MalfunctionMar 24, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT FOR RIGHT OPHTHALMIC ARTERY SEGMENT ANEURYSM, THE PHENOM27 SHAPABLE MICROCATHETER WAS GUIDED TO THE LEFT M2. ACCORDING TO THE DIAMETER OF THE BLOOD VESSEL AT THE ANEURYSM LOCATION, A 4.75-25 STENT WAS SELECTED. THE INNER AND OUTER PACKAGING WERE INTACT, AND HYDRATED THE BLOOD FLOW DIVERSION DENSE MESH STENT. THE STENT WAS DELIVERED ALONG THE PHENOM27 AND DEPLOYED AFTER THE STENT WAS IN PLACE. AFTER TRYING TO DEPLOY THE STENT SEVERAL TIMES, THE TIP END COULD NOT BE OPENED AND THE STENT COULD NOT BE DEPLOYED. THE STENT AND THE SHAPABLE MICROCATHETER WERE THEN REMOVED AND REPLACED WITH A 4.75-20 STENT, WHICH WAS SUCCESSFULLY DEPLOYED AND THE SURGERY WAS COMPLETED. THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676860 ↗
• MalfunctionJul 9, 2024Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE DISTAL END OF THE INTERMEDIATE CATHETER DID NOT MOVE, AND THE STENT CATHETER WAS WITHDRAWN TO DEPLOY THE STENT. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. MULTIPLE PIPELINES HAD NOT BEEN USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19698342 ↗
• MalfunctionMar 4, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. IT WAS NOTED THAT THE TIP END OF THE PIPELINE WAS IN THE STRAIGHT SECTION OF THE MIDDLE CEREBRAL ARTERY, AND AFTER REPLACING WITH THE NEW STENT, THE SAME OPERATION COULD BE OPENED SMOOTHLY. ADDITIONAL STEP/DEVICE ATTEMPTED TO OPEN THE PIPELINE INCLUDED PUSHING INTERMEDIATE CATHETER TO GO UPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826648 ↗

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-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-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