Pipeline TM Flex Embolization Device with Shield Technology TM PED2-500-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000449568), received between Oct 23, 2025 and Sep 29, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Off-Label Use; Retraction Problem; Use of Device Problem; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938531 ↗
• MalfunctionAug 17, 2026Material Frayed; Material Deformation; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278780 ↗
• MalfunctionApr 24, 2026Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE ENCOUNTERED RESISTANCE AND FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED FLOW DIVERSION THERAPY ANEURYSM LOCATED ON THE OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 12MM AND A 7MM NECK DIAMETER. THE LANDING ZONE WAS 4.2MM DISTALLY AND 5.1MM PROXIMALLY. ACCESS VESSEL WAS THE FEMORAL ARTERY AND IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED DURING THE PROCEDURE. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THERE WAS OBVIOUS CONTRAST RETENTION WITHIN THE ANEURYSM, WITH NO VESSEL LOSS. IT WAS REPORTED THAT THE SPECIFIC SITUATION WAS THAT THE ANEURYSM WAS RELATIVELY LARGE AND THE VESSEL WAS HIGHLY TORTUOUS, SO THE CUSTOMER SPENT A LONG TIME ESTABLISHING ACCESS. AFTER THE MICROCATHETER WAS POSITIONED, IT REACHED TO THE M1-M2 BEND, AND STENT DELIVERY WAS INITIATED. THE INITIALLY SELECTED STENT WAS A PED2-500-20. THE CUSTOMER STARTED STENT DELIVERY AND REPORTED SIGNIFICANT RESISTANCE DURING DELIVERY. AFTER SUCCESSFUL POSITIONING, STENT DEPLOYMENT WAS STARTED. WITH THE STENT LOCATED IN THE STRAIGHT SEGMENT OF M1, THE CUSTOMER BEGAN WITHDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982166 ↗
• MalfunctionMar 25, 2026Unintended Movement; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LESION WAS A SACCULAR ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY SEGMENT. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION AND WAS NOT PLACED IN A BEND WHEN IT FAILED TO OPEN. SOME ADDITIONAL STEPS TAKEN IN AN ATTEMPT TO OPEN THE PIPELINE WERE RETRIEVEMENT AND REDEPLOYMENT. THE TIP END DID NOT OPEN SUFFICIENTLY, RESULTING IN INADEQUATE ANCHORING WAS DEEMED A CONTRIBUTING FACTOR FOR THE MOVEMENT/DISLODGMENT. MULTIPLE DEVICES WERE NOT BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING DURING THE PROCESS. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION AND JUMPED DURING THE DEPLOYMENT. THE CATHETER TIP WAS WITHDRAWN DURING DEPLOYMENT AND ANY CAUSE OR CONTRIBUTING FACTORS TO THE TIP FAILURE TO OPEN WERE NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687491 ↗
• MalfunctionMar 16, 2026Activation Failure

  IT WAS REPORTED THAT A PIPELINE EMBOL DEVICE 5.00MM X 20MM WAS USED DURING A PROCEDURE TO TREAT AN UNRUPTURED, SACCULAR INTRACRANIAL ANEURYSM LOCATED IN THE RIGHT CAROTID ARTERY WITH A MAXIMUM DIAMETER OF 5 MM AND A NECK DIAMETER OF 6 MM. AFTER ACCESS WAS ESTABLISHED AND THE STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER APPROXIMATELY 7-8 MM OF THE STENT TIP END WAS DEPLOYED, THE OPERATOR WAITED ABOUT 10 SECONDS BUT THE TIP END DID NOT OPEN. DEPLOYMENT WAS CONTINUED FOR ANOTHER 12 MM, YET THE TIP END STILL FAILED TO OPEN. THE OPERATOR ATTEMPTED RETRIEVING AND REDEPLOYMENT; DESPITE MANEUVERS SUCH AS SHAKING AND PUSH-PULL, THE TIP END REMAINED UNOPENED. FURTHER ADJUSTMENTS INCLUDING MODIFYING MICROCATHETER TENSION, WERE UNSUCCESSFUL. THE STENT WAS THEN REMOVED FROM THE PATIENT'S BODY, AND IT WAS FOUND THAT THE TIP END OF THE STENT COULD NOT OPEN. THE STENT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LANDING ZONE WAS 4.7MM DISTAL AND 5MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24606266 ↗
• MalfunctionMar 3, 2026Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS WERE IDENTIFIED FOR THE RESISTANCE OR FOR THE FAILURE TO OPEN. RESISTANCE WAS NOTED AT THE DISTAL PORTION OF THE CATHETER, AND A KINK WAS OBSERVED AT THE DISTAL END AFTER REMOVAL. NO DAMAGE TO THE PIPELINE PUSHWIRE WAS OBSERVED. RE SHEATHING WAS ATTEMPTED AS AN ADDITIONAL STEP TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496465 ↗
• MalfunctionFeb 9, 2026Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER ADVANCING THE PED-500-20 STENT THROUGH THE MARKSMAN TO THE M2 SEGMENT, THE OPERATOR BEGAN DEPLOYING THE TIP END AT THE M1 SEGMENT, TAKING ADVANTAGE OF THE STRAIGHT PORTION. THE STENT DELIVERY CATHETER WAS SLOWLY WITHDRAWN TO EXPOSE THE PROXIMAL RADIOPAQUE MARKER COIL. THE MICROCATHETER WAS FURTHER WITHDRAWN TO RELEASE THE STENT TIP END, BUT AFTER DEPLOYING APPROXIMATELY 6 MM, THE STENT FAILED TO OPEN PROPERLY. THE OPERATOR CONTINUED TO DEPLOY A LONGER SEGMENT, ATTEMPTING TO UTILIZE THE STENT'S SELF-EXPANSION FORCE TO OPEN, AND DEPLOYED ABOUT 16 MM, AT WHICH POINT THE DELIVERY CATHETER TIP REACHED THE INTERNAL CAROTID ARTERY, BUT THE STENT TIP STILL FAILED TO OPEN. SUSPECTING THAT THE SMALL WINGS AT THE STENT TIP WERE CONSTRAINING IT, THE OPERATOR RETRIEVED THE STENT AND ATTEMPTED IN VIVO FLIPPING OF THE SMALL WINGS, THEN REDEPLOYED THE STENT. AFTER WITHDRAWING THE STENT DELIVERY CATHETER TO EXPOSE THE RADIOPAQUE MARKER COIL AND DEPLOYING ABOUT 5 MM, THE OPERATOR ADVANCED THE DELIVERY GUIDEWIRE AND CONTINUED TO DEPLOY 4 MM, BUT THE STENT STILL FAILED TO OPEN. THE OPERATOR THEN PULLED THE WHOLE STENT TO THE DISTAL END OF THE INTERNAL CAROTID ART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290910 ↗
• MalfunctionJan 22, 2026Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE TIP FAILING TO OPEN WAS NOT DETERMINED. THE PIPELINE FAILED TO OPEN AT THE DISTAL SECTION AND WAS NOT PLACED IN A BEND WHEN THE FAILURE OCCURRED. ADDITIONAL STEPS TAKEN TO OPEN THE PIPELINE WERE RETRIEVAL BY PUSHING AND PULLING. THERE WAS NO OBSERVED DAMAGE TO THE PIPELINE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151445 ↗
• MalfunctionDec 19, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE HAD FAILED TO OPEN IN THE DISTAL SECTION AND WAS FOUND TO HAVE FRAYED EDGES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.4 MM AND A 2.6 MM NECK DIAMETER. LANDING ZONE: DISTAL:4.5 MM AND PROXIMAL: 4.9 MM. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 2. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT ANEURYSM. IT WAS REPORTED THAT FOR PREOPERATIVE PREPARATION, AN 8F TERUMO FEMORAL SHEATH WAS USED FOR PUNCTURE, WITH THE RIGHT FEMORAL ARTERY AS THE PUNCTURE SITE. AS THE PATIENT HAD PREVIOUSLY UNDERGONE ANGIOGRAPHY, A 5F MPA LONG SINGLE-CURVE CATHETER WAS DIRECTLY USED TO GUIDE THE LEE KAI MEDICAL 8F DELIVERY CATHETER (PICA8F90MPS) TO THE RIGHT C1 SEGMENT. THE EV3 INTRACRANIAL SUPPORT CATHETER (5F NAVIEN, RFX058-115-08, LOT NUMBER: B771489) WITH INTACT PACKAGING WAS OPENED, AND WATER INJECTION SHOWED NO ISSUES. AFTER CONNECTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853526 ↗
• MalfunctionDec 3, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704687 ↗
• MalfunctionOct 23, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation Failure; Activation, Positioning or Separation Problem; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DEFORMATION OF THE GUIDE WIRE COATING WAS OBSERVED, BUT NO OTHER DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS NOTED. IN BOTH DEVICES, THE DISTAL END OF THE PIPELINE DID NOT OPEN, AND NEITHER STENT WAS PLACED IN A VESSEL BEND WHEN THE ISSUE OCCURRED. NO ADDITIONAL STEPS OR DEVICES WERE ATTEMPTED TO OPEN THE PIPELINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368213 ↗

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-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-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-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