PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000284671), received between Jul 27, 2022 and Sep 4, 2025 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DISTAL FLARE AND TRUMPETING IS REFERRING TO THE DISTAL DEVICE NOT OPENING IN A UNIFORM FASHION AND THE DISTAL END APPEARING DAMAGED WHEN REMOVED FROM BODY. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964825 ↗
• MalfunctionSep 20, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALTERNATIVE PIPELINE DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO CATHETER ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271008 ↗
• MalfunctionJun 12, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. 5 X 10 PIPELINE WAS DELIVERED THROUGH THE PHENOM 27 OUT INTO THE LEFT M1. IT WAS UNSHEATHED BUT WOULD NOT OPEN. IT WAS RESHEATHED, REDEPLOYED PULLED BACK CLOSE TO THE DESIGNATED LANDING ZONE, AND PUSHED OUT HALFWAY. THE MIDSECTION OPENED, BUT NOT THE DISTAL PORTION EVEN AFTER A FAIR AMOUNT OF MANIPULATION. THE PIPELINE WAS NOT PLACED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.  THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, AMORPHOUS ANEURYSM IN THE LEFT PCOM REGION. THE MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 4.48MM AND THE PROXIMAL LANDING ZONE WAS 3.8MM. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH AN ACCESS DIAMETER OVER 5MM PROXIMALLY. NO PATIENT SYMPTOSM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19516876 ↗
• InjuryApr 5, 2024Structural Problem; Malposition of Device; Activation, Positioning or Separation Problem; Activation Failure; Structural Problem; Malposition of Device; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE MANUFACTURER REPRESENTATIVE (REP) BELIEVES THE CAUSE OF THE PIPELINE FAILURE WAS DEPLOYING THE DEVICE PRIOR TO SEEING ANY SORT OF OPENING OF THE DEVICE (COMPLETELY "RIBBONED/FLATTENED"). THIS INFORMATION WAS CONFIRMED WITH THE STAFF AT THE ACCOUNT. IT WAS REPORTED THAT P2Y12: 115, THE ANEURYSM WAS NOT RUPTURED, AND THE ANEURYSM DIMENSIONS WERE 6MM HEIGHT, 7MM NECK.

  Patient problems: Failure of Implant; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19051539 ↗
• MalfunctionFeb 23, 2024Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WOULD NOT OPEN DISTALLY OR ANY OTHER PORTION (PROXIMAL, MIDDLE). HEALTHCARE PROVIDER (HCP) RECAPTURED 3 TIMES, WAGGED, AND PERFORMED ALL KNOWN "TRICKS" TO OPEN LAZY DEVICE WITH NO LUCK. WINGS WERE FLIPPED OFF THE DISTAL END. HCP WANTED TO REPLACE DEVICE FOR NEW DEVICE. WHEN THEY PULLED THE PIPELINE AND SYSTEM OUT, THE STENT ITSELF WAS STILL "STRETCHED" ONTO THE CORE WIRE PROVING NO DEPLOYMENT OR STENT OPENING HAD HAPPENED. HCP REPLACED 500-10 DEVICE FOR A 475-12 DEVICE AND IT WORKED WITH NO ISSUES. 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 MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT CAROTID SEGMENT ANEURYSM. THE LANDING ZONE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770250 ↗
• InjuryNov 22, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO IMPLANT THIS FIRST PIPELINE. THE DISTAL END OF THE DEVICE WOULD NOT OPEN. HCP TRIED RESHEATHING THE PTFE SLEEVES MULTIPLE TIMES AND IT STILL WOULD NOT OPEN. THE MIDDLE PART OF THE PIPELINE WAS POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. HCP WITHDREW THE DEVICE FROM THE PATIENT AND WENT WITH THE NEXT DEVICE. THE HCP TRIED TO TRIED TO DEPLOY THE SECOND PIPELINE AND FAILED DUE TO THE DEVICE NOT OPENING CORRECTLY PROXIMALLY AND THE DEVICE LOOKED DAMAGED, POSSIBLY FROM RESHEATHING, SO THE HCP REMOVED AND WENT FOR A THIRD DEVICE. MORE THAN 50% OF THE SECOND PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE MIDDLE PORTION OF THE PIPELINE WAS POSITION ED IN A BEND. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE HCP ATTEMPTED A THIRD PIPELINE AND IT WOULD ALSO NOT OPEN PROPERLY PROXIMALLY. MORE THAN 50% OF THE THIRD PIPELINE HAD

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 18193518 ↗
• MalfunctionNov 15, 2023Off-Label Use; Activation Failure; Off-Label Use; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT ADMITTED AT THE HOSPITAL WITH HEADACHES. PATIENT EVALUATED BY THE HEALTHCARE PROVIDER (HCP) WHO DETERMINED PATIENT HAD A 22MM LEFT CAROTID TERMINUS ANEURYSM. PATIENT STARTED ON DUAL ANTIPLATELET THERAPY (DAPT) AND 2 DAYS LATER BROUGHT TO ANGIO SUITE FOR PIPELINE EMBOLIZATION. ACCESS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY USING A NEURON MAX 90CM SHEATH. LEFT MIDDLE CEREBRAL ARTERY ACCESSED WITH PHENOM 027 CATHETER AND ARISTOTLE 018 WIRE. PHENOM PLUS PARKED IN COMMUNICATING SEGMENT OF CAROTID ARTERY FOR INTERMEDIATE SUPPORT DURING PROCEDURE. 5.0X10 PIPELINE SHIELD DEVICE SELECTED AND PREPARED PER IFU. PIPELINE DEVICE WAS ADVANCED THROUGH THE PHENOM 027 MICROCATHETER. HCP ATTEMPTED TO DEPLOY DEVICE INTO LEFT MCA. DURING DEPLOYMENT THE DEVICE FAILED TO OPEN ON THE DISTAL END. THE MIDDLE SEGMENT OF THE DEVICE OPENED BUT THE DISTAL DEVICE REMAINED CLOSED. MULTIPLE ATTEMPTS WERE MADE TO RESHEATH AND REDEPLOY DEVICE. THE DEVICE WAS RE-SHEATHED IN PHENOM 027 AND REMOVED FROM PATIENT. A SECOND DEVICE 5.0X12 WAS OPENED AND PREPPED PER IFU. THE SECOND DEVICE ALSO FAILED TO OPEN ON THE DISTAL END IN THE SAME MANNER AS THE FIRST DEVICE. THE DISTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139806 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CONSENSUS NOW IS THAT THE PATIENT WAS HAVING SEIZURES AND THE ISSUES WERE NOT RELATED TO THE PIPELINE PROCEDURE. THE PATIENT IS DOING WELL AND BACK TO BASELINE.

  Patient problems: Ischemia Stroke

  MAUDE report 17878375 ↗
• MalfunctionSep 14, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT BOTH PIPELINES WERE ATTEMPTED TO BE OPENED AFTER WINGS FLIPPED IN STRAIGHT M1, WITH GREATER THAN 50% OF THE PIPELINE OUT OF THE MICROCATHETER. NEITHER PIPELINES WOULD OPEN AT THE DISTAL END OR MIDDLE. BOTH DEVICES WERE THEN RECOVERED 25% THEN DRAGGED BACK TO THE INTERNAL CAROTID ARTERY (ICA) AND PUSHED OUT AND STILL WOULD NOT OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT ICA ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 2MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE WAS 4MM DISTALLY AND 5.2MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED WITH A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 63. THE POST PROCEDURE ANGIOGRAPHIC RESULT WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749007 ↗
• MalfunctionSep 14, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT BOTH PIPELINES WERE ATTEMPTED TO BE OPENED AFTER WINGS FLIPPED IN STRAIGHT M1, WITH GREATER THAN 50% OF THE PIPELINE OUT OF THE MICROCATHETER. NEITHER PIPELINES WOULD OPEN AT THE DISTAL END OR MIDDLE. BOTH DEVICES WERE THEN RECOVERED 25% THEN DRAGGED BACK TO THE INTERNAL CAROTID ARTERY (ICA) AND PUSHED OUT AND STILL WOULD NOT OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT ICA ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 2MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE WAS 4MM DISTALLY AND 5.2MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED WITH A PLATELET REACTIVITY UNITS (PRU) LEVEL OF 63. THE POST PROCEDURE ANGIOGRAPHIC RESULT WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17748993 ↗
• MalfunctionSep 12, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE SHIELD STENTS THAT HAD FISH-MOUTHING AT THE DISTAL END DURING DEPLOYMENT. THAT PATIENT WAS UNDERGOING A PROCEDURE FOR TREATMENT OF A RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) PARAOPHTHALMIC SEGMENT BLISTER ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 1MM AND THE NECK DIAMETER WAS 2MM. THE DISTAL LANDING ZONE WAS 3.8MM AND THE PROXIMAL LANDING ZONE WAS 4.89MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; PRU LEVEL WAS 67. IT WAS REPORTED THAT THE PIPELINES AND ALL ACCESSORY DEVICES WERE PREPARED AND USED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN FIST TRIED TO OPEN THE PIPELINE SHIELD (MODEL: PED2-475-12, LOT: B347741) IN THE DISTAL RIGHT ICA TO COVER THE ANEURYSM. THE DISTAL END OF THE PIPELINE WAS NOT OPENING DESPITE THE MIDDLE AND PROXIMAL SEGMENTS OPENING; THE DISTAL END APPEARED "FISH-MOUTHED." THE PHYSICIAN RESHEATHED THE DEVICE AND ATTEMPTED DEPLOYMENT 2 MORE TIMES BUT THE DISTAL END WAS STILL CRIMPED. IT WAS NOTED THAT MORE THAT 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND. THE PIPELINE WAS RESH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727995 ↗
• MalfunctionAug 1, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PED WOULD NOT OPEN IN THE DISTAL SEGMENT. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE AND "WAG" WITHOUT SUCCESS. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SEGMENT. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT HAD BEEN RESHEATHED MORE THAN 2 TIMES AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE DEVICE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. ANOTHER DEVICE (SAME SIZE) WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED AND THE DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (OPHTHALMIC) WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. THE LANDING ZONE WAS 4MM ON THE DISTAL END AND 4.8MM ON THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. ANGIOGRAPHIC RESULT POST PROCEDURE WAS FULL APPOSITION AND SLIGHT CONTRAST STAGNATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439422 ↗
• MalfunctionMay 3, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY PARAOPTHLAMIC ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2.5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5 MM DISTALLY AND 5.2 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL IS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE STENT WAS NOT FULLY OPEN.  NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT FOR DEVICE 1 (PED2-500-10) THE DISTAL PORTION OF THE DEVICE WAS NOT OPENING AND LOOKED FRAYED. AFTER UNSUCCESSFULLY PUSHING MORE DEVICE OUT TO GET THE DEVICE OPEN, WE DECIDED TO TAKE THE DEVICE OUT AND GO WITH A NEW ONE. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE HAD BEEN DEPLOYED LESS THAN 50% WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16859776 ↗
• InjuryOct 10, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE GOAL WAS TO LAND THE PIPELINE AT THE INTERNAL CAROTID ARTERY (ICA) TERMINUS DISTALLY AND ALLOW THE PIPELINE TO COVER THE NECK OF THE ANEURYSM AND END PROXIMALLY AROUND THE OPHTHALMIC SEGMENT. THE FIRST PIPELINE WOULD NOT OPEN DISTALLY. THERE WERE REPEATED ATTEMPTS TO RECAPTURE AND RE-DELIVER THIS DEVICE ALTHOUGH IT WAS NOT OPENING AT ALL. THE FIRST PIPELINE WAS THEN REMOVED AND A 5X12 PIPELINE DEVICE WAS ATTEMPTED. THE SECOND PIPELINE ALSO SHOWED THE SAME LAZINESS TO OPEN DISTALLY AND WAS ALSO GIVEN MULTIPLE ATTEMPTS TO RE-CAPTURE AND DELIVER. THE SECOND PIPELINE WAS ALSO REMOVED SUCCESSFULLY. IT WAS THEN DECIDED TO STOP FOR THE NIGHT AND ATTEMPT A 3RD ATTEMPT THE NEXT DAY. ON THE NEXT DAY, THEY WERE SUCCESSFUL IN IMPLANTING A 4.5 X 12 PIPELINE IN THE TARGET LANDING AREA. THE PHENOM PLUS CATHETER THAT WAS USED WAS ACCIDENTALLY DISCARDED. BOTH PIPELINES WERE USED FOR AN INDICATION THAT IS APPROVED AND THE PIPELINES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETERS WERE FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15569091 ↗
• MalfunctionJul 27, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE SHIELD FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM LOCATED IN THE LEFT PARA OPHTHALMIC SEGMENT OF THE LEFT ICA WHICH HAD PREVIOUSLY BEEN TREATED. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.75MM DISTAL AND 4.75MM PROXIMAL. IT WAS REPORTED THAT THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE PIPELINE LOOKED OPEN AND GOOD, AND THE PHYSICIAN WAS SATISFIED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THAT THE PATIENT HAD AN EXISTING PIPELINE CONSTRUCT IN RIGHT ICA DONE IN 2020 WITH A 4.5 X 20 PIPELINE FLEX AND 5.0 X 18 PIPELINE FLEX. IT WAS DISCOVERED THAT THE DISTAL PIPELINE WAS NOT OPEN AND WAS GETTING WORSE. THEY USED A BALLOON TO TRY AN OPEN, AND WHEN IT DIDN¿T WORK, THEY ADDED AN ADDITIONAL PIPELINE SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118166 ↗

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-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-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