PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000284336), received between Mar 25, 2022 and Feb 24, 2026 — classified as 9 injuries, 12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD WHICH HAD TIP COIL BREAK. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF A 7MM SACCULAR ANEURYSM WHICH HAD A 5MM NECK. PATIENT'S VESSEL TORTUOSITY WAS MODERATE.  IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICE WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE THE DISTAL PUSHWIRE TIP COIL BROKE/DETACHED. THE ENTIRE DEVICE WAS RETRIEVED. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. POST PROCEDURE ANGIOGRAPHIC RESULTS WERE ACCEPTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430446 ↗
• MalfunctionDec 23, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT A PIPELINE EMBOLIZATION DEVICE WAS USED TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF THE PIPELINE DEVICE, THE DEPLOYMENT WIRE BECAME STUCK ON THE PTFE SLEEVES DURING RETRACTION. THE DEPLOYMENT WIRE WAS SUBSEQUENTLY REMOVED TOGETHER WITH THE PHENOM 27 MICROCATHETER THROUGH THE DEPLOYED PIPELINE STENT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, WITH A PLATELET REACTIVITY UNIT LEVEL OF 90. ANGIOGRAPHIC IMAGING POST PROCEDURE CONFIRMED SUCCESSFUL DEPLOYMENT OF THE PIPELINE FLEX. VESSEL TORTUOSITY WAS MINIMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN RESPONSE TO THE EVENT, THE DOCTOR OFF LABEL "FLIPPED THE PTFE SLEAVES" OUTSIDE THE BODY PLACING THE DISTAL TIP OF THE PIPELINE DEVICE INTO A BOWL FILLED WITH SALINE, THEN PUSHED OUT THE RADIOPAQUE DISTAL WIRE EXPOSING THE PTFE SLEAVES AND PARTIALLY OPENING THE PIPELINE STENT UNDERWATER, THEN RETRACTING AND "FLIPPING" THE PTFE SLEAVE AND RETRACTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885715 ↗
• MalfunctionDec 9, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT PTFE SLEEVES WOULDN'T FLIP ON THE PIPELINE. THEY COULDN'T PULL PUSHER WIRE THROUGH THE PHENOM AND COULDN'T RECAPTURE THE PUSHER WIRE. THEY HAD TO PULL THE ENTIRE SYSTEM OUT TOGETHER. PUSHER WIRE/DELIVERY SYSTEM STUCK IN CATHETER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761042 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE STENT HAD COMPLICATIONS. SUBJECT CAME TO THE EMERGENCY ROOM WITH COMPLAINTS OF HEADACHE AND BLURRY OF VISION, PRIOR MRA HEAD REVEALED BILATERAL CAROTID STENOSIS. THE PATIENT WAS HOSPITALIZED FORM (B)(6) 2025. THE EVENT RESOLVED ON 2025-JUN-19. ASSESSED AS POSSIBLY RELATED TO PROCEDURE, DISEASE UNDER STUDY AND ANTIPLATELET MEDICATION AND PROBABLY RELATED TO STUDY DEVICE. 3 YEAR FOLLOW-UP IMAGING THAT BRANCHES ARISING FROM THE PARENT ARTERY HAVE A DEGREE OF STENOSIS: - OPHTHALMIC; 76%-95%. MRS SCORE AT 3 YEAR VISIT OF 1 HOWEVER MRS SCORE AT 1 YEAR VISIT WAS 0. BASELINE ANEURYSM DETAILS: SIDE (HEMISPHERE): RIGH.T SEGMENT OF INTERNAL CAROTID ARTERY (ICA): C6. LOCATION OF ANEURYSM IN VESSEL: SIDEWALL. ANEURYSM MORPHOLOGY: SACCULAR. MAXIMUM ANEURYSM DIAMETER: 5MM. ANEURYSM DOME HEIGHT: 4MM. ANEURYSM DOME WIDTH: 3MM. ANEURYSM NECK SIZE: 3MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 4MM. NO STASIS AT THE END OF THE PROCEDURE.

  Patient problems: Blurred Vision; Headache; Stenosis

  MAUDE report 22468844 ↗
• MalfunctionMay 7, 2025Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE ISSUES IDENTIFIED WITH THE PHENOM CATHETER USED. NO CAUSE DETERMINED. SITE ONLY STATED ¿"STENT HAD MIGRATED CAUDALLY, POST DEPLOYMENT. NOW WITHOUT FULL COVERAGE OF THE NECK OF THE ANEURYSM." SITE REPORTED MIGRATION MONTHS BEFORE CORE-LAB REPORTED ANGIOGRAPHICALLY OCCLUDED BRANCH OF ANTERIOR CEREBRAL ARTERY AND PCOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975500 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPONSOR ASSESSED THE VASOSPASM AS CAUSED BY THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEADACHE AND BRUISING ON 26-SEP-2024.

  Patient problems: Bruise/Contusion; Headache; Ischemia Stroke; Vasoconstriction

  MAUDE report 21635486 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED MULTIPLE PUNCTATE RECENT INFARCTS WITHIN THE RIGHT CEREBRAL HEMISPHERE, LIKELY RELATED TO ANGIOGRAPHY.

  Patient problems: Ischemia Stroke

  MAUDE report 21580124 ↗
• InjuryMar 11, 2025Device Dislodged or Dislocated; Unintended Movement; Migration; Device Dislodged or Dislocated; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN MENTIONED THE EVENT OCCURRED AFTER THE DSA FU AT 1YEAR. THEY DID NOT SPECIFIED TO ME A DATE: DSA FU WERE PERFORMED BETWEEN DECEMBER2024 /JANUARY 2025. THE MORPHOLOGY OF EACH ANEURYSM WAS UNKNOWN AT THE TIME OF THE REPORT. B355381-SHIELD- ALA- PIPELINE DISPLACED NOT RESOLVED. THE DOCTOR WAS PLANNING A NEAR FUTURE RE-INTERVENTION. THE PATIENT HAS LOW BLOOD COMPLICATIONS AND HAS BEEN POSTPONED. SYMPTOMS: REFILLING OF THE ANEURYSM. ANEURYSM IS GETTING BIGGER SINCE LAST DSA PERFORMED ON (B)(6) 2025.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575359 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WERE NO ISSUE IDENTIFIED WITH THE PHENOM CATHETER USED.

  Patient problems: Blurred Vision; Headache; High Blood Pressure/ Hypertension; Intracranial Hemorrhage; Ischemia Stroke; Loss of Vision; Nausea; Necrosis; Obstruction/Occlusion; Paresthesia; Stenosis; Vomiting

  MAUDE report 20348226 ↗
• MalfunctionSep 10, 2024Activation, Positioning or Separation Problem; Unintended Movement; Migration; Activation, Positioning or Separation Problem; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED DAY 30 THAT WALL APPOSITION WAS NOT ACHIEVED. HOWEVER, IT WAS PREVIOUSLY NOTED THAT WALL APPOSITION WAS ACHIEVED WITH THE SECOND DEVICE. THERE WERE NO ISSUES REPORTED WITH THE PHEOM CATHETER. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 20180963 ↗
• MalfunctionMar 29, 2024Malposition of Device; Activation, Positioning or Separation Problem; Activation Failure; Malposition of Device; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN AND DEPLOYED PREMATURELY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC INTERNAL CAROTID ARTERY (ICA). THE LANDING ZONE WAS 3.3MM DISTALLY AND 4.09MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT WAS THE PIPELINE DEPLOYED SUCCESSFULLY BUT PREMATURELY. THE PIPELINE DISTAL END LANDED IN THE M1 WHICH WAS NOT INTENDED. IT WAS REPORTED THAT THE DOCTOR PLACED THE GUIDE CATHETER (BENCHMARK 071) JUST DISTAL TO THE HORIZONTAL PETROUS. THEY THEN SENT THE PHENOM 27 WITH THE ARISTOTLE 24 WIRE INTO THE DISTAL M1 SEGMENT. THEY THEN PULLED THE WIRE AND PUSHED THE 4X14 PIPELINE SHIELD THROUGH THE PHENOM 27. THEY STARTED TO UNSHEATH THE PHENOM 27 TO OPEN UP THE DISTAL END OF THE PIPELINE. THEY EXPOSED APPROXIMATELY 1/3 OF THE PIPELINE AND IT TOOK A CIGAR SHAPE. THE DISTAL AND PROXIMAL END WERE PINCHED, WHILE THE MIDDLE OF THE DEVICE OPENED UP. THEY THEN RESHEATHED THE PIPELINE TO PUSH THE SLEEVES OFF AND IT THEN UNSHEATHED THE DEVICE IN THE SAME SPOT. THE DEVICE OPENED UP THIS TIME. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19004690 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPONSOR ASSESSED THE EVENT AS UNRELATED TO THE PROCEDURE OR DEVICE, AND POSSIBLY RELATED TO ANTIPLATELET THERAPY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 18915109 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE SUBJECT PRESENTED TO THE EMERGENCY DEPARTMENT WITH RECTAL BLEEDING AND SHORTNESS OF BREATH FOR PAST MONTH POST INDEX PROCEDURE AND START OF DUAL ANTIPLATELET THERAPY (DAPT). AN ENDOSCOPY SHOWED DUODENAL AVMS. ACTIVE BLEEDING TREATED WITH APC, HEMOSTATIC CLIPS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2024. THE EVENT WAS TREATED WITH A SURGICAL PROCEDURE. THE OUTCOME STATUS WAS RECOVERED/RESOLVED ON (B)(6) 2024. THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY, DID NOT RESULT IN NEW OR WORSENING NEUROLOGICAL DEFICITS AND DIDN'T RESULT FROM A DEVICE DEFICIENCY. THE SITE ASSESSED THE EVENT AS PROBABLY RELATED TO ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE OR PROCEDURE.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, SIDEWALL ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY C6 WITH A MAX DIAMETER OF 5.2MM AND A 4.6MM NECK DIAMETER. THE DOME HEIGHT WAS 2.5MM AND WIDTH WAS 5.2MM. THE PARENT ARTERY DISTAL TO THE ANEURYSM WAS 3.2MM AND 3.6MM PROXIMALLY. RAYMOND AND ROY WAS CLASS 3 AT THE END OF THE PROCEDURE. THERE WAS NO STASIS AND COMPLETE NECK COVERAGE. THE STUDY DEVICE WAS SUCCESSFULLY IMPLANTED IN THE SUBJECT AND WALL AP

  Patient problems: Fatigue; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18589987 ↗
• MalfunctionDec 19, 2023Difficult or Delayed Positioning; Unintended Movement; Physical Resistance/Sticking; Difficult or Delayed Positioning; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THERE WAS NO RESISTANCE TO THE CATHETERS. THERE WAS NO DAMAGE TO THE PUSHWIRE. ONLY THE SINGLE PIPELINE WAS BEING USED WHEN MOVEMENT OCCURRED. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360285 ↗
• MalfunctionAug 10, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL END DID NOT OPEN. THE PIPELINE WAS PLACED IN A BEND WHEN IT FAILED TO OPEN. RESHEATHING WAS AN ADDITIONAL STEP USED TO TRY AND OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17497864 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT BRUISED EASILY SINCE STARTING PLAVIX POST PROCEDURE. TWO LARGE BRUISES WERE NOTED ON THE LEFT UPPER AND LOWER ARM AND RIGHT UPPER ARM. SAFETY ASSESSED AS POSSIBLY RELATED TO ANTIPLATELET THERAPY. THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY, DID NOT RESULT FROM A DEVICE DEFICIENCY, AND DID NOT RESULT IN NEW OR WORSENING NEUROLOGICAL DEFICITS. THE EVENT DID NOT RESULT IN ANY TREATMENT. THE PIPELINE WAS SUCCESSFULLY IMPLANTED AND WALL APPOSITION WAS ACHIEVED. THERE WAS NO FLATTENING OR TWISTING OF THE DEVICE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON POST OP DAY 2 (POD-2) THE PATIENT WAS NOTED TO HAVE DROP IN HEMOGLOBIN (6.3) WITHOUT ANY SYMPTOMS. PATIENT RECEIVED 2 UNITS OF PRBC AND POST TRANSFUSION HEMOGLOBIN LEVEL WAS 10.5. THE SUBJECT WAS DISCHARGED HOME WITH HOME HEALTH ON (B)(6) 2022. NO INDICATION OF BASELINE MH OF ANEMIA. THE PATIENT HAD UNDERGONE TREATMENT FOR A SACCULAR, SIDEWALL ANEURYSM LOCATED IN THE C7 SEGMENT OF THE RIGHT ICA. THE MAX DIAMETER WAS 3.8MM, THE DOME HEIGHT WAS 7.6MM, THE DOME WIDTH WAS 3.8MM, AND THE NECK SIZE WAS 2.8MM. THE PARENT ARTERY DIAMETER WAS 3.4MM DISTAL TO THE ANEURYSM AND 3.6MM PROXIM

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16004319 ↗
• MalfunctionOct 28, 2022Break; Unintended Ejection; Retraction Problem; Physical Resistance/Sticking; Break; Unintended Ejection; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER THE DEVICE WAS BACK FLUSHED, THE PLASTIC SHEATH WAS ADVANCED INTO THE HUB OF THE MICR OCATHETER, AND THE PUSHWIRE WAS ADVANCED. RESISTANCE WAS IMMEDIATELY FELT, PUSHING WAS STOPPED AND THE PUSHWIRE WAS PULLED BACK TO RETRIEVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15692615 ↗
• MalfunctionMay 27, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN PROXIMALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 3.5MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.4MM DISTAL AND 3.6MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE WAS PARTIALLY DEPLOYED IN THE RIGHT ICA OPHTHALMIC REGION, BUT DUE TO HIGH POSTERIOR GENU AND PROXIMAL TORTUOSITY THE DEVICE WAS CONSTRAINED (RIBBON) PROXIMALLY DURING DEPLOYMENT. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO UNDO THE CONSTRAIN BY RESTHEATHING AND LOADING INTO THE GENU. THE PIPELINE WAS REMOVED AND A REPLACEMENT WAS SUCCESSFULLY IMPLANTED. THE MIDDLE AND PROXIMAL SEGMENTS HAD BEEN POSITIONED IN A BEND WHEN IT FAILED TO OPEN, AND MORE THAN 50% HAD BEEN DEPLOYED. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE REPLACEMENT DEVICE WAS SUCCESSFULLY DEPLOYED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522859 ↗
• MalfunctionMay 23, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT OPEN DISTALLY. THE PHYSICIAN RECAPTURED TWICE FOR BOTH BUT THEY WOULD NOT OPEN. THE PIPELINES WERE REMOVED AND A PED2-425-14 WAS USED, AND THE ISSUE WAS RESOLVED. THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE DEVICE WAS NOT USED OFF-LABEL AND THE PIPELINE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS THERAPEUTIC. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED VERY GOOD RESULTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN OPTHALMIC WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471479 ↗
• MalfunctionMay 23, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT OPEN DISTALLY. THE PHYSICIAN RECAPTURED TWICE FOR BOTH BUT THEY WOULD NOT OPEN. THE PIPELINES WERE REMOVED AND A PED2-425-14 WAS USED, AND THE ISSUE WAS RESOLVED. THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE DEVICE WAS NOT USED OFF-LABEL AND THE PIPELINE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS THERAPEUTIC. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED VERY GOOD RESULTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN OPTHALMIC WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471433 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT WHO WAS IMPLANTED WITH 3 PIPELINE DEVICES EXPERIENCED VISUAL SYMPTOMS, HEADACHE, AND MUSCLE WEAKNESS. THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, SIDE BRANCH ANEURYSM LOCATED IN THE C6 SEGMENT OF THE LEFT ICA. THE MAX DIAMETER WAS 6.5MM, THE DOME HEIGHT WAS 5.5MM, THE DOME WIDTH WAS 5.6MM, AND THE NECK SIZE WAS 3.7MM. ALL 3 PIPELINES WERE SUCCESSFULLY IMPLANTED WITH COMPLETE NECK COVERAGE AND WALL APPOSITION ACHIEVED, AND THERE WAS SIGNIFICANT STASIS IN THE ANEURYSM POST PROCEDURE. THE OPHTHALMIC SIDE BRANCH WAS COVERED BY THE DEVICES. IT WAS REPORTED THAT PATIENT EXPERIENCED BILATERAL BLURRY VISION IMMEDIATELY AFTER A PROCEDURE. THIS IMPROVED THE SAME NIGHT. THE PATIENT ALSO EXPERIENCED A SEVERE HEADACHE (RATED 6/10), WITH THROBBING LOCALIZED WITH THE LEFT FRONTAL REGION OCCURRING THE SAME DAY AS THE PROCEDURE IN THE SAME REGION AS THE TREATED ANEURYSM. THE HEADACHE WAS ASSOCIATED WITH PHOTO/PHONOPHOBIA, WHICH WAS MANAGED BY ORAL MEDICATION. THE NEXT DAY THEY EXPERIENCED VISUAL FIELD DEFICIT, WITH SOME BLURRINESS IN THE UPPER VISUAL FIELD OF THEIR LEFT EYE. THIS INVOLVED APPROXIMATELY 10% OF THE VISUAL FIELD WHICH REMAINED STABLE

  Patient problems: Blurred Vision; Headache; Hematoma; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 13912917 ↗

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-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