PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000284558), received between Sep 27, 2021 and Jan 21, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (15 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF A PIPELINE DEVICE FAILED TO OPEN AND UPON REMOVAL APPEARED TO HAVE BURRS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C7 POSTERIOR COMMUNICATING ARTERY. THE DIMENSIONS OF THE ANEURYSM HAD A MAX DIAMETER OF 2MM, 1MM NECK DIAMETER, AND A LANDING ZONE OR ARTERY SIZE OF 4MM DISTALLY AND 6MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED WITH A NORMAL PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS MULTIPLE ANEURYSMS IN THE C7 SEGMENT. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE ANEURYSMS IN THE POSTERIOR COMMUNICATING SEGMENT, INCLUDING TWO SMALL ANEURYSMS MEASURING 2×1 AND 2×0.5. DURING THE DEPLOYMENT OF THE STENT, THE DISTAL END FAILED TO OPEN. MULTIPLE ATTEMPTS WERE MADE, BUT IT STILL FAILED TO OPEN. UPON REMOVAL OF THE DENSE MESH STENT, BURRS WERE OBSERVED ON THE TIP END. TO ENSURE PATIENT SAFETY, A NEW DENSE MESH STENT (PED2-425-25) WAS USED INSTEAD, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130261 ↗
• MalfunctionJan 20, 2026Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSES OF BOTH THE STENT FAILURE TO OPEN AND THE STENT DAMAGE WERE NOT DETERMINED. BOTH PIPELINE DEVICES SHOWED FRAYING AT THE DISTAL ENDS, AND THE DISTAL SECTION OF EACH PIPELINE DID NOT OPEN. THE PIPELINE DEVICES HAD NOT BEEN PLACED IN A VESSEL BEND WHEN THEY FAILED TO OPEN. ADDITIONAL STEPS OR DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24118343 ↗
• MalfunctionAug 4, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED A TOTAL OF TWO PIPELINES AND TWO MARKSMAN 150S FAILED TO OPEN. THE THIRD ONE DID NOT EXPERIENCE ISSUES AND WAS DEPLOYED NORMALLY. THE THIRD ONE USED A PHENOM 27 MICROCATHETER. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709962 ↗
• MalfunctionJun 5, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH UNKNOWN DIAMETERS. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE DISTAL AND PROXIMAL WERE UNKNOWN. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT THE DISTAL END OF THE STENT WAS NOT OPENED PROPERLY AND ATTEMPTS TO RETRIEVE AND DEPLOY THE STENT FAILED TO FULLY OPEN THE STENT. THE PHYSICIAN TRIED TO RETRIEVE THE STENT INTO THE MICROCATHETER AND DEPLOY IT. AFTER REPLACEMENT, THE STENT WAS SUCCESSFULLY IMPLANTED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED INTRACRANIAL ANEURYSM. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE CAUSE OF THE FAILURE TO OPEN DETERMINED. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151855 ↗
• MalfunctionMar 24, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS PLACED IN A STRAIGHT SEGMENT WHEN IT FAILED TO OPEN. THE PIPELINE WAS RETRIEVED FOR DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676875 ↗
• MalfunctionFeb 18, 2025Unintended Ejection; Material Separation; Material Deformation; Unintended Ejection; Material Separation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE WAS DETACHED DURING THE SECOND RETRIEVAL AND COULD NOT BE USED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4 MM AND NECK DIAMETER 5 MM. LANDING ZONE (ARTERY SIZE): DISTAL 12 MM AND PROXIMAL 10 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED (PRU LEVEL 0). THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401057 ↗
• MalfunctionDec 2, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE, SPECIFICALLY, THE PHYSICIAN RETRIEVED THE STENT AND RAISED THE INTERMEDIATE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821695 ↗
• MalfunctionNov 6, 2024Collapse; Material Deformation; Activation Failure; Collapse; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.1MM AND A 3.1MM NECK DIAMETER. THE LANDING ZONE WAS 3.8MM DISTALLY AND 4.4MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7.3MM. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE PRU LEVEL WAS IN NORMAL RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL HEALTH. IT WAS REPORTED THAT WHEN TREATING AN ANEURYSM OF RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT, THE FEMORAL ARTERY WAS PUNCTURED, AND A KANDELAI LONG SHEATH SUCCESSFULLY REACHED THE INTERNAL CAROTID ARTERY C1 SEGMENT. A NAVIEN SUCCESSFULLY REACHED THE CAVERNOUS SINUS POSTERIOR CURVE, AND AN ECHELON10 SUCCESSFULLY REACHED THE ANEURYSM UNDER SYCHRO GUIDANCE. A PHENOM REACHED THE RIGHT MIDDLE CEREBRAL ARTERY M1 UNDER SYCHRO GUIDANCE. A PED SHIELD-4.5-25 STENT WAS SELECTED ACCORDING TO 3D, ROUTINE OPERATION AND HYDRATION WERE PERFORMED, AND IT WAS SUCCESSFULLY DELIVERED TO M1 SEGMENT. PUSHED AG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622631 ↗
• MalfunctionOct 1, 2024Unintended Ejection; Activation Failure; Unintended Ejection; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE PREMATURELY RELEASED FROM THE RESHEATHING PAD. THE SURGEON SAID IT SHOULD BE. THE PUSHWIRE DID NOT BREAK/SEPARATE INTO MULTIPLE PIECES. THE SURGEON SAID THERE WAS DISPLACEMENT DURING THE DEPLOYMENT OF THE MIDDLE AND REAR SEGMENTS. THE PROXIMAL END OF THE PIPELINE DID NOT OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349269 ↗
• MalfunctionSep 16, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL END OF THE PIPELINE DIE NOT OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE PHYSICIAN PUSHED THE INTERMEDIATE CATHETER TO GO UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20226278 ↗
• MalfunctionAug 20, 2024Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ADDITIONAL ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE PIPELINE FAILURE. THERE WAS NO DAMAGE TO THE CATHETER NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001944 ↗
• MalfunctionJun 13, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS TREATED FOR AN INTERNAL CAROTID ARTERY (ICA) DISSECTION. VESSEL TORTUOSITY WAS MODERATE. THE PATIENT CAME WITH A STROKE AND IS RECOVERING WELL. THERE WERE NO SYMPTOMS RELATED TO THE DEVICE MALFUNCTION. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS EXCELLENT AFTER REMOVING THE PIPELINE THAT MALFUNCTIONED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER TYPE OF STENT. THE PIPELINE WAS PLACED IN A STRAIGHT VESSEL. ADDITIONAL STEPS IN ATTEMPT TO OPEN THE DEVICE INCLUDED RESHEATHING, WIRE/CATHETER, AND BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117103 ↗
• MalfunctionOct 12, 2022Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING SURGERY FOR RETREATMENT OF VERTEBRAL SIDE WALL ANEURYSM. VESSEL TORTUOSITY WAS NORMAL. THE PATIENT IS STABLE/GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592332 ↗
• MalfunctionApr 27, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WAS ABLE TO NAVIGATE UP TO THE ICA AND INTO THE MCA WITH THE ARISTOTLE 14 WIRE FOLLOWED BY THE PHENOM 27 MICROCATHETER. THE PHYSICIAN EXCHANGED THE WIRE FOR THE DEVICE WITHOUT ISSUE. THEY WERE ABLE TO SUCCESSFULLY UNSHEATH/PUSH THE DEVICE SO THAT IT BEGAN TO OPEN IN THE MCA. THEY DRAGGED AND DROPPED THE DEVICE SO THAT THE DISTAL END OF THE DEVICE BEGAN TO OPEN IN THE HORIZONTAL SEGMENT JUST DISTAL TO BOTH PARA OPTHALMIC ANEURYSMS. THE DEVICE WAS OPENING OPTIMALLY ON THE DISTAL END. WHILE COMING AROUND THE ANTERIOR GENU THE DEVICE FAILED TO OPEN. THE PHYSICIAN ATTEMPTED MULTIPLE ATTEMPTS TO OPEN THE DEVICE AROUND THE GENU BUT COULD NOT GET IT TO OPEN. THEY CONTINUED TO DEPLOY THE DEVICE ON THE PROXIMAL END OPEN JUST AS THEY FINISHED DEPLOYING THE DEVICE. WHILE TRYING TO RECAPTURE THE SLEEVES SO THAT THEY COULD POST PROCESS THE DEVICE EITHER WITH A J WIRE OR BALLOON TECHNIQUE, THE MICROCATHETER WOULD NOT PASS THE UNOPENED MIDDLE PORTION. AT THIS POINT IT WAS DETERMINED THE DEVICE WAS TWISTED THROUGH A SERIES OF DIFFERENT ANGLES AND IMAGES. THE SLEEVES HAD TO BE RETRACTED BACK THROUGH THE PARTIALLY OPENED DEVICE AND PASSED THE POINT OF TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222548 ↗
• MalfunctionNov 30, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 3 PIPELINES FAILED TO OPEN.  THE PATIENT WAS UNDERGOING SURGERY FOR AN "ANEURYSM TREATED WITH FRED." IT WAS A RUPTURED ANEURYSM WITHIN THE LEFT INTERNAL CAROTID ARTERY, IN A BLISTER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.  IT WAS REPORTED THAT THEY COULD NOT GET THE DISTAL END OF ALL DEVICES OPENED, TRIED THREE DIFFERENT DEVICES. THE DEVICES WERE NOT PLACED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED "LESS THAN OR EQUAL TO 2 TIMES." THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINES. THE PIPELINES WERE USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL), IN A RUPTURED BLISTER. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE DEVICES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899459 ↗
• MalfunctionSep 27, 2021Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL PART OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, PRIMARILY SACCULAR ANEURYSM WITH A FUSIFORM NECK COMPONENT LOCATED IN THE RIGHT CAVERNOUS ICA. THE MAX DIAMETER WAS 15.5MM, AND THE NECK DIAMETER WAS 6.5MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.2MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE ACT VALUE WAS 197. IT WAS REPORTED THAT DIFFICULTY WAS NOTED AS THE PIPELINE PASSED THROUGH THE CERVICAL SEGMENT DUE TO THE PATIENT'S ANATOMY. THE DISTAL PART OF THE PIPELINE WAS OBSERVED TO HAVE LAZY OPENING, AND THE PHYSICIAN QUESTIONED WHETHER THE STENT WAS TWISTED AS IT APPEARED TO SHOW DIFFICULTY OPENING ON THE ANTERIOR X-RAY. ANGIOGRAPHIC IMAGING WAS UNABLE TO CONFIRM TWISTING OF THE STENT; HOWEVER, DUE TO THE CONFIRMATION OF LATERAL X-RAY PLANE NOT SHOWING A RIBBONING EFFECT, A NOTE WAS MADE THAT THE ANATOMY WAS EXTREMELY TORTUOUS AND HAD MULTIPLE TURNS IN MULTIPLE DIRECTIONS. IT WAS NOTED THAT 3D IMAGING AVAILABLE COULD SUGGEST A VASCULAR ANOMALY THAT COULD HAVE BEEN CAUSING THE PIPELINE TO APPEAR AS THOUGH IT WAS NOT OPENING ALL THE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538362 ↗

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-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