PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00763000284602), received between Oct 27, 2021 and Sep 11, 2026 — classified as 1 death, 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (25 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735144 ↗
• MalfunctionDec 9, 2025Collapse; Structural Problem; Activation, Positioning or Separation Problem; Collapse; Structural Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT A PATIENT WITH A MEDICAL HISTORY OF PATENT FORAMEN OVALE, TRANSIENT ISCHEMIC ATTACK, AND AN UNRUPTURED LEFT OPHTHALMIC ANEURYSM PREVIOUSLY TREATED WITH PIPELINE EMBOLIZATION UNDERWENT 180-DAY FOLLOW-UP IMAGING. THE IMAGING REVEALED SIGNIFICANT PARENT ARTERY STENOSIS OF 51%-75% AND INCOMPLETE WALL APPOSITION OF THE PIPELINE EMBOLIZATION DEVICE, WHICH HAD PREVIOUSLY BEEN REPORTED AS COMPLETE. THE FINDINGS WERE CONFIRMED BY THE CORE LAB AND ADJUDICATION COMMITTEE. THE POOR WALL APPOSITION COULD BE ATTRIBUTED TO VESSEL STENOSIS AND INTIMATE HYPERPLASIA. THE EVENT WAS POSSIBLY RELATED TO ANTIPLATELET MEDICATION AND HAD A PROBABLE RELATIONSHIP WITH THE STUDY PROCEDURE AND DEVICE. THE PARENT ARTERY STENOSIS (IN STENT STENOSIS) WAS A FINDING BASED ON IMAGING AND NO SYMPTOMS OR TREATMENT WERE REPORTED BY THE SITE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A BALLOON WAS USED TO IMPROVE WALL APPOSITION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RIGHT C6 BIFURCATION BRANCH ANEURYSM WITH A MAX DIAMETER OF 3.8 MM AND A 1.9 MM NECK DIAMETER. THE ANEURYSM DOME HEIGHT WAS 3.6 MM, DOME WIDTH WAS 3.3 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS

  Patient problems: Hyperplasia; Stenosis

  MAUDE report 23758198 ↗
• MalfunctionJun 4, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE EMBOLIZATION STENTS FAILED TO OPEN AT THE DISTAL SECTION. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED RIGHT ICA- CAVERNOUS SEGMENT ANEURYSM WITH UNKNOWN MAX DIAMETER AND A 3.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.75MM DISTALLY AND 4.75MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.  IT WAS REPORTED THAT TWO PIPELINE WERE PREPARED PER IFU. THE PHYSICIAN ADVANCED THE DEVICE DISTAL TO THE PHENOM 27 CATHETER, POSITIONING IT IN THE STRAIGHT SEGMENT OF THE M1. ONCE THE TIP COIL OF THE PIPELINE WAS ALIGNED WITH THE CATHETER, THE PHYSICIAN BEGAN DEPLOYMENT, UNSHEATHING APPROXIMATELY ONE-THIRD OF THE BRAID. WITH LITTLE SUCCESS IN OPENING THE DISTAL BRAID, THE PHYSICIAN PROCEEDED TO FLIP THE PTFE SLEEVES. ADDITIONAL MANEUVERS WERE ATTEMPTED, INCLUDING DEPLOYING MORE BRAID, WAGGING, RESHEATHING, AND PUSHING THE DELIVERY WIRE, BUT THE BRAID REMAINED CONSTRICTED. AS THE DISTAL SEGMENT BEGAN TO TRUMPET, THE PHYSICIAN ELECTED TO REMOVE THE DEVICE, AND REPLACED WITH SAME TYPE OF DEVICE. HOWEVER, THE REPLACEMENT DEVICE ALSO FAILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145345 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT 1 YEAR FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) ON (B)(6) 2025. THERE WAS 76%-95% PARENT ARTERY STENOSIS. PER THE ADJUDICATION COMMITTEE, THERE WAS EVIDENCE OF SIGNIFICANT PARENT ARTERY STENOSIS > 50. BRANCHES HAD A DEGREE OF STENOSIS. THE POSTERIOR COMMUNICATING (PCOM) ARTERY WAS ANGIOGRAPHICALLY OCCLUDED. OPHTHALMIC WAS 26%-50%. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL 113%. THE PATIENT UNDERWENT SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT HEMISPHERE, C6 SIDEWALL ANEURYSM WITH A MAX DIAMETER OF 8.0MM AND A NECK DIAMETER OF 3.7MM. THE LANDING ZONE WAS 4.0MM DISTALLY AND 4.5MM PROXIMALLY. PATIENT MEDICAL HISTORY INCLUDES: PREVIOUS CIGARETTE SMOKER, ADHD, SLEEP APNEA, DEPRESSION, ANXIETY, BORDERLINE PERSONALITY DISORDER. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Stenosis

  MAUDE report 22059498 ↗
• MalfunctionMay 13, 2025Material Frayed; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Frayed; Retraction Problem; Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CATHETER RESISTANCE WAS NOTICED DURING RETRIEVAL. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010556 ↗
• MalfunctionMay 6, 2025Material Frayed; Activation Failure; Material Frayed; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFYING THE REPORT THAT THE PIPELINES HAD A "FLUTED APPEARANCE" WAS REFERRING THEN TAKING THE SHAPE OF A "BIRD BEAK APPEARANCE." IT WAS ALSO NOTED THAT THE STENTS APPEARS A LITTLE FRAYED AFTER REMOVAL. THE CAUSE WAS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971577 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT CEC ADJUDICATED THE EVENT AS CAUSAL TO PROCEDURE AND POSSIBLE TO DEVICE.

  Patient problems: Headache; Stenosis; Thrombosis/Thrombus

  MAUDE report 21766978 ↗
• MalfunctionMar 27, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE DISTAL END OF THE DEVICE WOULD NOT OPEN AFTER MORE THAN 50% HAD BEEN DEPLOYED. THE PATIENT HAD A MEDICAL HISTORY OF A GASTRIC POLYP AND WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT SUPRACLINOID SEGMENT, WITH SEVERE VESSEL TORTUOSITY NOTED. THE MAX DIAMETER WAS 11.17MM AND THE NECK DIAMETER WAS 6.5MM. THE DISTAL LANDING ZONE WAS 3.59MM AND THE PROXIMAL LANDING ZONE WAS 4.30MM. UPON THE INITIAL STEPS OF EXPOSING THE DISTAL END OF THE PIPELINE IN M1 ARTERY, HE PUSHED THE DELIVERY WIRE AND THE RETRACTED THE MICROCATHETER BUT COULDN'T GET THE DISTAL END TO OPEN AS THEY KEPT UNSHEATHING TO GET THE BODY OPEN IT STILL WOULD NOT OPEN THE DISTAL END. THERE WAS PLENTY OF ROOM IN THE STRAIGHT M1 SEGMENT AND IT WAS EXPECTED TO OPEN WITHOUT ISSUE. CONTINUED TO PUSH WIRE AND ALLOWED THE BODY TO OPEN ALL THE WAY TO THE TERMINUS. THEN RESHEATHED THE DEVICE AND TRIED ANOTHER TIME AND WOULD NOT OPEN. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED WITH A PLATELET REACTIVITY UNIT LEVEL OF 173. THE DEVICE WAS PREPARED AND DELIVERED THROUGH A PHENOM 27 150

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21711019 ↗
• MalfunctionMar 24, 2025Activation Failure; Activation Failure

  AFTER THE FIRST DEVICE DID NOT OPEN IT WAS THE PHYSICIAN WAS NOT COMFORTABLE WITH CONTINUING SO WE GOT ANOTHER SAME SIZE DEVICE WITH THE SAME LOT# AND HAD THE SAME EXACT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21682322 ↗
• MalfunctionFeb 5, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PREMATURE DEPLOYMENT OCCURED WHEN ATTEMPTING TO RESHEATH THE DEVICE. THE PUSHWIRE ROTATED OR PULLED BACK IN ORDER TO RESHEATH. THREE DEVICES WERE RETURNED. ONE REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21318446 ↗
• MalfunctionJan 9, 2025Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE ADVERSE EVENT OF TINNITUS. THE CLINICAL EVENTS COMMITTEE ASSESSED IT AS NOT RELATED TO THE PROCEDURE AND DEVICE, POSSIBLY RELATED TO ANTIPLATELET THERAPY (APT).

  Patient problems: Failure of Implant; Fatigue; Headache; Hearing Impairment; Stenosis

  MAUDE report 21120758 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE SUBJECT PRESENTED TO THE ER ON (B)(6) 2024 WITH COMPLAINTS OF HEADACHE, RIGHT FACIAL NUMBNESS, AND KALEIDOSCOPE VISION. CTA SHOWED NO ACUTE ABNORMALITY. THE SUBJECT TREATED WITH MIGRAINE COCKTAIL. IT WAS NOTED THE ADVERSE EVENT (AE) WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY. AE DID NOT RESULT FROM A DEVICE DEFICIENCY. THE AE WAS NOTED AS NOT RELATED TO ANTIPLATELET. THE SUBJECT WAS ADMINISTERED 10 MG METOCLOPRAMIDE, NACL BOLUS, AND MAGNESIUM SULFATE BOLUS (MIGRAINE COCKTAIL). THE PATIENT RECOVERED/RESOLVED (B)(6) 2024. NO PREVIOUS REPORT OF HEADACHE WAS NOTED. THE PATIENT WAS BEING TREATED FOR A LEFT C6 ICA BIFURCATION BRANCH ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAXIMUM DIAMETER 4.8 MM, DOME HEIGHT 4.4 MM, DOME WIDTH 4.8 MM, NECK SIZE 4.2 MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 4 MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM WAS 5 MM. POST IMPLANT COMPLETE STASIS AND NECK COVERAGE WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT THE ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END THE PROCEDURE WAS CLASS 3. THE ACCESS VESSEL WAS THE FEMORAL RIGHT. RIST WAS NOT USED. THE STUDY DEVICE WAS SUCCESSFULL

  Patient problems: Headache; Numbness; Stenosis; Visual Disturbances

  MAUDE report 20924021 ↗
• MalfunctionDec 6, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING THE PIPELINE EMBOLIZATION DEVICE, THE DISTAL END OF THE PIPELINE DEVICE FAILED TO OPEN ON TWO OCCASIONS. THE DEVICE WAS POSITIONED IN A BEND AT THE MIDDLE SECTION FOR BOTH DEVICES. MORE THAN 50% HAD BEEN DEPLOYED WHEN THE DEVICES FAILED TO OPEN. THE DEVICE WAS RESHEATHED MORE THAN TWO TIMES IN BOTH INSTANCES AND SUBSEQUENTLY REMOVED FROM THE PATIENT EACH TIME. THE DOCTOR TRIED "ALL THE TRICKS" TO GET THE DEVICE OPEN AND IT WOULD NOT WORK. THE PROCEDURE WAS COMPLETED BY IMPLANTING A SURPASS FLOW DIVERTER, WHICH RESULTED IN A SATISFACTORY ANGIOGRAPHIC OUTCOME. THE ANEURYSM WAS LOCATED IN THE INTERNAL CAROTID ARTERY, UNRUPTURED, WITH A SACCULAR MORPHOLOGY, A MAXIMUM DIAMETER OF 5.3 MILLIMETERS, AND A NECK DIAMETER OF 2.3 MILLIMETERS. THE LANDING ZONE MEASURED 3.9 MILLIMETERS DISTALLY AND 4.7 MILLIMETERS PROXIMALLY, WITH MODERATE VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20872613 ↗
• MalfunctionMar 15, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN DEPLOYED THE PIPELINE AS INDICATED PER INSTRUCTIONS FOR USE (IFU) AND THE DISTAL END WOULD NOT OPEN. HE RE-SHEATHED AND TRIED AGAIN WITH THE SAME RESULT. HE RE-SHEATHED A SECOND TIME AND THE DISTAL END WOULD NOT OPEN. THE PROXIMAL PORTION OF 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 WAS NO ANY ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR FULL DEPLOYMENT OF A 4.75X12 PIPELINE FLEX WITH SHIELD FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE WAS ABOUT 3.75MM DISTALLY AND ABOUT 4.65MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A PHENOM 27 150CM  MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914118 ↗
• InjuryJan 9, 2024Collapse; Activation, Positioning or Separation Problem; Activation Failure; Lack of Effect; Collapse; Activation, Positioning or Separation Problem; Activation Failure; Lack of Effect

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL LANDING ZONE WAS APPROXIMATELY 3MM FROM THE ANEURYSM NECK, AND THE DEGREE OF CONTRAST ST ASIS IN THE ANEURYSM WAS FELT TO BE INADEQUATE FOR SINGLE PIPELINE COVERAGE OF THE ANEURYSM. MULTIPLE PIPELINES WERE USED DUE TO THE PHYSICIAN'S DECISION. NO ADVERSE EVENT OR DEVICE DEFICIENCY WAS REPORTED AT THIS TIME, AND IT WAS UNKNOWN IF THERE WAS ANY ADDITIONAL INTERVENTION REQUIRED OR IMPACT TO THE PATIENT.

  Patient problems: Failure of Implant; Hyperplasia; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Stenosis

  MAUDE report 18479967 ↗
• MalfunctionJan 4, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 8 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.21 MM AND PROXIMAL: 4.77 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN GAINED ACCESS AND DELIVERED THE PIPELINE THROUGH THE MICROCATHETER AND BEGAN DEPLOYMENT. THE PHYSICIAN RESHEATHED ONE TIME TO PUSH PTFE WINGS BACK AND BEGAN TO UNSHEATH. THE DISTAL END CAME OPEN BUT NOT COMPLETELY. THE PHYSICIAN CONTINUED TO DEPLOY BUT DISTAL END STILL WOULD NOT OPEN. HE RESHEATHED ONE MORE TIME AND PUSHED DEVICE OUT BUT DISTAL END DID NOT OPEN COMPLETELY. DECISION WAS MADE TO REMOVE DEVICE AND START AGAIN WITH A NEW PIPELINE. PROCEDURE COMPLETELY SUCCESSFULLY. IT WAS REPORTED THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449155 ↗
• MalfunctionJan 3, 2024Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. MULTIPLE ATTEMPTS WERE MADE TO GET THE DEVICE TO OPEN PROPERLY. THE DEVICE WAS NOT DEPLOYED DUE TO IT NOT OPENING. THE PIPELINE WAS PLACED IN A DISTAL 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 INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE WAS 3.3MM DISTALLY AND 4.7MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANGIOGRAPHIC RESULT POST PROCEDURE REVEALED SUCCESSFUL PLACEMENT OF ANOTHER PIPELINE DEVICE. ANCILLARY DEVICES INCLUDE A RIST 079 REF (B)(4); LOT 20101-01 SHEATH, PHENOM PLUS FG19120-1030-1S ; LOT 225638850 GUIDE CATHETER, PHENOM 27 FG15150

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18440364 ↗
• InjuryNov 22, 2023Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DOCTOR NOTED THAT THERE WAS "NO, NOT REALLY" ANY RESISTANCE. IT WAS NOTED THAT THE PATIENT WAS DOING WELL AND A FRED FLOW DIVERTER WAS USED AFTER NOT BEING ABLE TO USE PIPELINE. THEY NEEDED TPA FOR VISUAL COMPLAINTS, BUT THAT IS RESOLVED. ANCILLARY DEVICES INCLUDED PHENOM 27, REF #(B)(6), LOT #226258434, PHENOM 27, REF #(B)(4), LOT #226624220.

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

  MAUDE report 18194139 ↗
• MalfunctionNov 21, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPENED AND APPEARED STUCK. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SECTION. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED PER 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 WIDE NECK OPHTHALMIC, UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 4.5MM DISTALLY AND 4.7MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULTS WERE GOOD. ANCILLARY DEVICES INCLUDE A PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND BALT COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186090 ↗
• DeathAug 31, 2023No Apparent Adverse Event; No Apparent Adverse Event

  2023-AUG-03 (B)(6) (HCP, REP): MEDTRONIC RECEIVED A REPORT THAT THE PATIENT PRESENTED WITH A GIANT ANEURYSM. THE PHYSICIAN TREATED IT BY PLACING TWO STRYKER COILS IN THE ANEURYSM AND LAID A PIPELINE SHIELD ACROSS THE NECK OF THE ANEURYSM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN AND PLAVIX. ON (B)(6) 2023 THE PATIENT RETURNED TO THE HOSPITAL IN THE EMERGENCY ROOM WITH A SUBARACHNOID HEMORRHAGE. THE PATIENT WAS BROUGHT TO INTERNAL RADIATION FOR IMAGING AND FOUND TO HAVE RUPTURED THE PREVIOUSLY TREATED ANEURYSM. THE PHYSICIAN THEN PLACED TWO MORE PIPELINE SHIELD DEVICES ACROSS THE NECK OF THE ANEURYSM TO TRY AND STOP THE BLEEDING. ON (B)(6) 2023 THE PATIENT CLOTTED OFF THEIR PARENT VESSEL WHERE THE TWO ADDITIONAL PIPELINES HAD BEEN PLACED. MANY ATTEMPTS WERE MADE TO CLEAR THE CLOT BUT THEY WERE NOT SUCCESSFUL. THE PATIENT PASSED AWAY ON (B)(6) 2023. THE PIPELINES WERE NOT USED FOR AN OFF-LABEL USE. THE PIPELINE DEVICES AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 25MM

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17664979 ↗
• MalfunctionMay 19, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN AND WAS DAMAGED. DURING PLACEMENT OF THE 4.75X14 PIPELINE THE DEVICE WAS PARTIALLY DEPLOYED IN THE RIGHT M1. ONCE THE DISTAL SEGMENT STARTED TO OPEN IT WAS PULLED BACK TO POSITION WHERE IT SEEMED TO BE DAMAGED. THE DISTAL SEGMENT NO LONGER LOOKED NORMAL. DEVICE WAS REMOVED AND ANOTHER DEVICE (5X12) WAS PLACED WITHOUT INCIDENT. GOOD PLACEMENT OF 5X12 PIPELINE SHIELD. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT OPTHALMIC LOCATION. THE MAX DIAMETER WAS 4.5MM AND THE NECK DIAMETER WAS 3.4MM. THE DISTAL LANDING ZONE WAS 4.05MM AND THE PROXIMAL LANDING ZONE WAS 4.70MM. VESSEL TORTUSOITY WAS MINIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16962382 ↗
• MalfunctionApr 20, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE WAS DEFECTIVE. NO OTHER INFORMATION WAS RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE DISTAL END OF THE PIPELINE WOULD NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781415 ↗
• MalfunctionApr 12, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE'S FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE HYPOPHOSEAL WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 4.5 MM DISTALLY AND 4.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 100. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING PED2-450-14 THE PHYSICIAN TRIED TO DEPLOY A PED2-475-14 AND A PED2-475-12 AND THEY BOTH HAD THE "TULIP" SHAPE AT THE DISTAL END AND WOULD NOT OPEN. HE TRIED RESHEATHING 3 TIMES FOR BOTH AND THEY WOULD NOT OPEN. HE HAS HAD THIS HAPPEN A NUMBER OF TIMES AND IS GROWING FRUSTRATED WITH THESE SIZES. IT WAS REPORTED THERE WAS FAILURE TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723820 ↗
• MalfunctionDec 7, 2022Component or Accessory Incompatibility; Activation Failure; Component or Accessory Incompatibility; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE "FMD IN THE ICA" REFERRED TO FIBROMUSCULAR DYSPLASIA IN THE INTERNAL CAROTID ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932874 ↗
• MalfunctionJul 29, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE SHIELD FAILED TO OPEN IN THE DISTAL SECTION. THE HEALTHCARE PROVIDER (HCP) PROCEEDED TO SUCCESSFULLY ACCESS THE LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM VIA RADIAL APPROACH USING A 6 FR. FUBUKI LONG SHEATH. A PHENOM PLUS 120 CM WAS INSERTED JUST PROXIMAL TO THE LEFT ICA PARA-OPTHALMIC ANEURYSM AND THRU THE PHENOM PLUS AND PHENOM 27 150 CM WAS PLACE INTO THE PROXIMAL MIDDLE CEREBRAL ARTERY (MCA) DISTAL TO THE PREVIOUSLY INSERTED STRYKER ATLAS STENT. THE PIPELINE SHIELD 4.75X14 WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) THEN TRANSFERRED INTO THE PHENOM 27 FOR DELIVERY ACROSS THE PREVIOUS STENT/COIL ANEURYSM WHICH WHICH SHOWED A REOCCURRENCE. THE PIPELINE SHIELD WAS OPENED VIA UNSHEATHING IN THE LEFT MCA( M1) WITH PIPELINE STARTING TO OPEN DISTALLY OUTSIDE ATLAS STENT PORTION OF VESSEL, BUT AS THE HCP ¿PUSHED WIRE¿ TO DELIVER THE PIPELINE INTO THE ATLAS STENT PORTION OF THE ANEURYSM THE PIPELINE WOULD NOT OPEN. THE HCP TRIED ¿WAGGING¿ PIPELINE THEN RESHEATHING THE PIPELINE UP TO THE OPENED SECTION OF PIPELINE DISTALLY THEN TRIED TO AGAIN ¿PUSH WIRE¿ TO ATTEMPT TO OPEN THE PIPELINE. MANY TECHNIQUES WERE TRIED TO RE OPEN WITH NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136653 ↗

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-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-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