PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-425-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000284428), received between Nov 30, 2021 and Aug 27, 2026 — classified as 2 deaths, 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Medtronic received a report of a post-procedure adverse event (AE) of Pneumonia that is procedure related. It was reported that on 2024 (b)(6) new hospitalization occurred for the patient that encountered the AE of Pneumonia until 2024 (b)(6) with the outcome status of recovered/resolved. The AE resulted in treatment given Zyvox and Zosyn. The AE did was not treated with a blood transfusion, percutaneous intervention, or surgical procedure. No diagnostic tests or procedures were performed. The relative time from the index procedure was post-procedure. The AE was not related to the disease under study. It did not result in new or worsening of existing neurological deficits. The AE did not result from a device deficiency. The patient came in with right sided chest pain; troponins negative, increased white blood cell count and febrile. The patient was admitted with concern for Pneumonia. Infectious disease following on Zyvox and Zosyn for suspected HAP (hospital-acquired pneumonia). The blood cultures were negative. The site seriousness assessment concluded that there was no congenital anomaly, death, disability, life threatening, medical intervention present, however, hospitalization

  Patient problems: Bronchopneumonia; Chest Pain

  MAUDE report 50477567 ↗
• DeathFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING POST-OPERATION A PIPELINE DEVICE WAS FOUND TO HAVE THROMBOSIS IN THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE PARA-OPHTHALMIC SEGMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE FLOW DIVERSION IMPLANTATION EVENT. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS EQUIVALENT TO BASELINE. THE PATIENT STATUS AT THE TIME OF THE REPORT IS DECEASED AS OF (B)(6) 2026. IT WAS REPORTED THAT PATIENT WAS FOUND UNRESPONSIVE AT HOME. SUBSEQUENT IMAGING REVEALED THROMBOSIS OF THE PIPELINE DEVICE, RESULTING IN A MAJOR ISCHEMIC STROKE. THE PATIENT LATER DIED. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. ANCILLARY DEVICES INCLUDE A NON-MEDTRONIC (NEURON MAX) GUIDE CATHETER, A PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND A NON-MEDTRONIC (SYNCHRO 2) GUIDEWIRE.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus

  MAUDE report 24247891 ↗
• MalfunctionNov 26, 2025Retraction Problem; Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FLEX W/SHIELD TECHNOLOGY STENT PTFE SLEEVES COULD NOT BE RETRIEVED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663107 ↗
• MalfunctionAug 6, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED INTERNAL CAROTID ARTERY ANEURYSM. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.6MM DISTALLY AND 4.28MM PROXIMALLY. IT WAS REPORTED THAT THERE WAS NO ISSUE WITH THE TWO PIPELINE PED IMPLANTED STENTS. THE POLYTETRAFLUOROETHYLENE (PTFE) WINGS WOULD NOT ALLOW FOR RECAPTURE. IT APPEARED THAT WINGS NEVER ACTUALLY FLIPPED AND WERE CORKED INSIDE THE MICROCATHETER. THE PUSHWIRE (CAPTURE COIL) GOT STUCK DURING RETRACTION AT THE TIP OF THE MICROCATHETER, AND IT WAS NOT ROTATED DURING REMOVAL. THE PUSHWIRE AND THE CATHETER WERE NOT DAMAGED. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS GOOD. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). 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 22725542 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT OF AN AMORPHOUS, UNRUPTURED LEFT OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 3.5MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.8MM DISTALLY AND 4.0MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.    IT WAS REPORTED THAT THE FIRST PIPELINE EMBOLIZATION STENT WAS PLACED AT TARGET LOCATION SUCCESSFULLY, THEN THE 2ND PIPELINE WAS ADVANCED TO M1 VASCULATURE, AND THE TIP COIL WAS ADVANCED OUTSIDE PHENOM 27 CATHETER. WHEN PULLING STENT BACK TO TARGET LOCATION, THE WIRE WAS NOTICED TO BE MOVING FREELY. UNDER FLUOROSCOPY, THE WIRE WAS MOVING INDEPENDENTLY OF PIPELINEIMMEDIATELY PROXIMAL TO PROXIMAL BUMPER. THE PHYSICIAN REMOVED THE STENT AND PHENOM 27 TOGETHER AS A UNIT FROM THE PATIENT, THE DEVICE WAS PUSHED OUT OF CATHETER ON BACK TABLE WHERE THE DISTAL TIP OF THE DELIVERY SYSTEM WAS DETACHED FROM THE PROXIMAL HYPOTUBE PUSHER. NO OTHER DAMAGE WAS NOTICED. THE ANATOMY WAS NORMAL WITH MINIMAL AT MOST TORTUOSITY. DEVICE WAS IN STRAIGHT SEGMENTS OF VESSEL WHEN MALFUNCTION OCCURRED. THE ANGIOGRAPHIC RESULT POST PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374070 ↗
• InjuryMay 30, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE SPONSOR ASSESSMENT REPORTED NOT RELATED TO DEVICE, PROCEDURE, DISEASE UNDER STUDY, OR ANTIPLATELET THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vertebral Fracture

  MAUDE report 22118399 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED 180 FOLLOW UP ANEURYSM OCCLUSION STATUS R CLASS 1.

  Patient problems: Stenosis

  MAUDE report 19229655 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE AE WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY. THE AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE SIDE BRANCHES NOTED: OPHTHALMIC. VISION IMPAIRMENT ¿ COTTON WOOL SPOT.

  Patient problems: Ischemia; Ischemia Stroke; Visual Impairment

  MAUDE report 19033054 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD A HEMORRHAGE 24 HOURS AFTER CASE. THE PATIENT WAS SENT TO THE OPERATING ROOM. 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 OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 3.7MM DISTALLY AND 4.25MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.   ANCILLARY DEVICES INCLUDE A PHENOM PLUS GUIDE CATHETER AND PHENOM 27 MICROCATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17966982 ↗
• MalfunctionSep 20, 2023Unintended Ejection; Activation Failure; Unintended Ejection; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DISTAL TO MIDDLE SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS IN A STRAIGHT M1 SEGMENT WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785412 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL PARENCHAL HEMORRHAGE FOLLOWING A PIPELINE IMPLANT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) AND A NTERIOR CHOROIDAL. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 2.47MM DISTAL AND 4.5MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 84. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A PIPELINE FLOW DIVERTER ON (B)(6) 2023. THERE WAS A PREVIOUSLY COILED PCOM ANEURYSM, AND THE FLOW DIVERTER COVERED BOTH THE PCOM AND THE ANTERIOR CHOROIDAL ANEURYSM. THE PROCEDURE WENT WELL AND THE PIPELINE WAS SUCCESSFULLY DEPLOYED WITH GOOD WALL APPOSITION. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON (B)(6) 2023. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GREAT. THEY WERE READMITTED TO THE HOSPITAL ON THE EVENING OF (B)(6) 2023 WITH DISTAL PARENCHYMAL HEMORRHAGE. THE PATIENT WAS ALIVE BUT WITH NEUROLOGICAL DEFICIT LEFT SIDE PARALYSIS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BENCHMARK 071 GU

  Patient problems: Confusion/ Disorientation; Intracranial Hemorrhage; Memory Loss/Impairment; Paralysis

  MAUDE report 16340424 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A PROCEDURE FOR DISTAL LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM EMBOLIZATION WITH COILS AND FLOW DIVERSION. THE ANEURYSM MAX DIAMETER WAS 17MM AND THE NECK DIAMETER WAS 10MM. BLOOD FLOW AND VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED WITH PRU LEVEL OF 80 NOTED. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). TWO PIPELINE FLEX WITH SHIELD STENTS WERE IMPLANTED; THE SECOND PIPELINE WAS PLACED TO ENSURE ADEQUATE DISTAL COVERAGE. THROMBUS WAS NOTED IN THE DOME OF THE ANEURYSM PRIOR TO PROCEDURE. DEPLOYMENT WAS STRAIGHTFORWARD WITH THE EXCEPTION OF SEMI-LIMITED VISUALIZATION DUE TO SIZE OF ANEURYSM. PROPER PLACEMENT AND APPOSITION WAS CONFIRMED WITH VIRTUAL DILUTION 3DRA. ON WEDNESDAY (B)(6) 2022, PATIENT PRESENTED WITH STROKE SYMPTOMS, SECONDARY TO THROMBOSIS WITHIN THE PIPELINE CONSTRUCT. VESSEL WAS REVASCULARIZED WITH ASPIRATION THERAPY AND PATIENT WAS ADMITTED TO ICU WITH AN NIHSS OF 23, INTUBATED, AND PARALYZED.

  Patient problems: Paralysis; Stroke/CVA; Thrombosis/Thrombus; Unspecified Nervous System Problem

  MAUDE report 16092041 ↗
• InjuryNov 8, 2022Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED FEMORAL GROIN ACCESS SITE BLEEDING AND DEVICE THROMBOSIS IDENTIFIED A POTENTIAL ADDITIONAL ADVERSE EVENT DURING PROCEDURE AND POST PROCEDURE, POSSIBLE RELATED TO THE PROCEDURE/DEVICE. ADDITIONALLY, IT WAS REPORTED THE PATIENT EXPERIENCED ALTERED MENTAL STATUS, EXPRESSIVE AND RECEPTIVE APHASIA, AND NUMBNESS. INTRASTENT THROMBUS RESULTED IN NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICITS AND SYMPTOMS LASTED FOR MORE THAN 24 HOURS. THE PATIENT REPORTED BILATERAL SUPERIOR HEMIANOPSIA ON POST OPERATIVE DAY 1 AND WAS TAKEN FOR RE-ANGIO. AN MRI OF THE BRAIN WAS ALSO DONE AFTER LEFT FACIAL DROOP 2 DAYS POST PROCEDURE. THE MRI SHOWED MULTIFOCAL INFARCTS. THE PATIENT WAS GIVEN IV INTEGRILIN LATER CONVERTED TO ADA AND BRILINIA FOR DEVICE THROMBOSIS. SAFETY ISSUED A QUERY FOR THE SITE TO CONFIRM IF ANY ADDITIONAL AE IS OCCURRED (POSSIBLE STROKE OR CEREBRAL INFARCTION PER MRI FINDINGS AND NEUROLOGICAL SYMPTOMS). THE FEMORAL SITE BLEEDING WAS TREATED BY AND ULTRASOUND OF VASCULAR LOWER EXTREMITY PSEUDOANEURYSM EVALUATION DUPLEX RIGHT. THE EVENT RESULTED IN HOSPITALIZATION. THE OUTCOME STATUS WAS UPDATED FROM RECOVERED/RESOLVED WITH SEQU

  Patient problems: Blurred Vision; Cognitive Changes; Dysphasia; Fatigue; Headache; Hematoma; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Numbness; Pain; Stroke/CVA; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Nervous System Problem; Visual Impairment

  MAUDE report 15753525 ↗
• MalfunctionAug 23, 2022Break; Unintended Ejection; Retraction Problem; Break; Unintended Ejection; Retraction Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE HAD ISSUES WHILE RESHEATHING. UPON RESHEATHING ON PIPELINE TO PUSH PTFE SLEEVES OUT OF THE WAY, THE DEVICE CAME OFF OF THE BACK BUMPER. THERE WAS THEN NO CONTROL. THE PHENOM PLUS WAS BROUGHT UP OVER THE 27 AND DEVICE AND EVERYTHING WAS THEN REMOVED FROM THE PATIENT. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PED2 WAS BEING USED FOR AN INDICATION THAT WAS NOT APPROVED AS IT WAS USED FOR A RUPTURED BLISTER ANEURYSM. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM IN THE INTERNAL CAROTID ARTERY. VESSEL TORTUOSITY WAS SEVERE. ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: CEREBASE, PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15279909 ↗
• MalfunctionAug 23, 2022Unintended Ejection; Unintended Movement; Physical Resistance/Sticking; Unintended Ejection; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE DISTAL PART OF THE PHENOM 27 MICROCATHETER WHILE RESHEATHING. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.3MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 142. IT WAS REPORTED THAT WHILE DEPLOYING THE PIPELINE THE DEVICE FELL BACK PROXIMAL TO THE ANEURYSM. RECAPTURE WAS NECESSARY TO SECURE A MORE DISTAL POSITION. THE DOCTOR WAS PUSHING VERY HARD TO TRY TO RECAPTURE THE DEVICE. THE FORWARD ENERGY ALLOWED THE PHENOM PLUS TO ADVANCE. THE DEVICE WAS MOSTLY RECAPTURED BUT WAS NO LONGER ON THE DEPLOYMENT SYSTEM. MOST OF THE DEVICE WAS STILL WITH IN THE PHENOM 27. BOTH THE PHENOM 27 AND PHENOM PLUS WERE REMOVED FROM THE BODY WITH THE PIPELINE WITHIN THE PHENOM 27. THEY REGAINED ACCESS AND USED A REPLACEMENT DEVICE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PHYSICIAN HAD NOT RELEASED THE LOAD/SLACK IN THE SYSTEM. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. THE PATIENT DID NOT EXPERIENCE ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276536 ↗
• InjuryJul 13, 2022Adverse 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 HAD COMPLICATIONS. SUDDEN VISION LOSS OF THE LEFT EYE ON (B)(6) 2022 AT 06:26 PM AND BURNING HEADACHE ON THE LEFT SIDE OF THE HEAD 10/10 IN INTENSITY. THE PATIENT WAS ADMITTED TO EMERGENCY DEPARTMENT CTA BRAIN IMAGING WAS UNREMARKABLE. WITHOUT STENT MIGRATION, VISION IMPROVED WITH BASELINE NORMAL VISUAL ACUITY. THE EVENT RESOLVED ON (B)(6) 2022. THE EVENT WAS POSSIBLY RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO ANTIPLATELET MEDICATION, RETREATMENT PROCEDURE OR STUDY DEVICE. THE PATIENT WAS BEING TREATED FOR A SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) C6 SIDEWALL. MAXIMUM ANEURYSM DIAMETER: 7 MM. ANEURYSM DOME HEIGHT: 5 MM. ANEURYSM DOME WIDTH: 6 MM. ANEURYSM NECK SIZE: 4 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.1 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 4.3 MM. SIGNIFICANT STASIS AT THE END OF THE PROCEDURE. COMPLETE NECK COVERAGE AT THE END OF THE PROCEDURE. RAYMOND AND ROY CLASS 1 OCCLUSION AT THE END OF THE PROCEDURE.

  Patient problems: Headache; Loss of Vision; Stroke/CVA

  MAUDE report 15009635 ↗
• MalfunctionJun 2, 2022Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE 425X16 WAS IMPLANTED WITHOUT ISSUE, HOWEVER, THE DISTAL LANDING ZONE WAS VERY CLOSE TO THE NECK. AN ADDITIONAL 425X14 WAS PLACED DISTAL TO THE FIRST PED. THE DEVICE MOVED PROXIMAL DURING PLACEMENT AND WOULD NOT RESHEATH. THE 425X14 WAS REMOVED AND A 425X12 WAS SUCCESSFULLY PLACED WITHOUT INCIDENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PIPELINE WAS NOT USED OFF-LABEL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED BUT THE PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE DEVICE WAS WELL APPOSED AND CONTRACT WAS STAGNATING IN THE ANEURYSM. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT ICA WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14578174 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED A HEMORRHAGE FOLLOWING A PIPELINE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.1MM DISTAL AND 4.2MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 7. IT WAS REPORTED THAT THERE WERE NO ISSUES WITH DEVICE PREPARATION OR DEPLOYMENT, AND TECHNICALLY THE PROCEDURE WENT GREAT. AS THE PATIENT WAS WAKING UP FROM ANESTHESIA THEY STARTED TO SEIZE. THEY WERE NOT WAKING UP, AND EXPERIENCED SEVERAL SEIZURES THROUGH OUT THE NEXT 24 HOURS. POST PROCEDURE CT AND MRI WERE CLEAN AT 6 HOURS. A REPEAT MRI AT 24 HOURS SHOWED HEMORRHAGE. THE PATIENT HAD NOT WOKEN SINCE, HAVING SPONTANEOUS MOVEMENT BUT WAS NON RESPONSIVE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BALLAST 088 SHEATH, PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO 14 GUIDEWIRE.

  Patient problems: Convulsion/Seizure; Intracranial Hemorrhage

  MAUDE report 13636238 ↗
• DeathNov 30, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DIED ON THE DAY OF THE PROCEDURE. THEY HAD PRESENTED AS UNRESPONSIVE WITH PARENCHYMAL HEMORRHAGE, LEFT FRONTAL. NO OTHER INTERVENTIONS WERE PERFORMED BETWEEN THE PIPELINE IMPLANT AND THE PATIENT DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12903572 ↗

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-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-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-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