PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000284503), received between Jul 13, 2020 and Feb 13, 2026 — classified as 6 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (15 reports).

12 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Unintended Ejection; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM. IT WAS REPORTED THAT DURING DELIVERY OF THE PIPELINE PED STENT VIA THE MICROCATHETER, THE STENT WAS OPENED WHEN INTRODUCED IN THE BODY BEFORE INTENDED. THE PED STENT WAS REMOVED, AND A NEW DEVICE WAS USED WITHOUT ISSUE. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS ACCEPTABLE. IT WAS UNKNOWN IF 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. ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CAUSE OF THE PREMATURE DEPLOYMENT WAS NOT DETERMINED. HOWEVER, THEY INDICATED THAT THE DISTAL PORTION OF THE DEVICE WAS ONLY PARTIALLY OPEN, PRESENTING A ¿FISHMOUTH¿ APPEARANCE. PREMATURE DEPLOYMENT OCCURRED WHEN THE DEVICE DID NOT OPEN FULLY AT THE DISTAL END. THE DISTAL PORTION APPEARED TO ¿FISHMOUTH,¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24339447 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT AN ADVERSE EVENT OCCURRED POST-PROCEDURE THAT ALLEGES A PIPELINE DEVICE INVOLVEMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY C6 VESSEL SIDEWALL. THE ANEURYSM DIMENSIONS WERE REPORTED AS HAVING A MAX DIAMETER OF 5.8MM, A 4.6MM NECK DIAMETER, A 4.6MM DOME HEIGHT, A 5.8MM DOME WIDTH AND THE PARENT ARTERY DIAMETER WAS 3.2MM DISTAL/4MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL RIGHT. NOT RIST WAS USED. POST IMPLANT SPECIFY SIGNIFICANT STASIS AT THE END OF THE PROCEDURE, COMPLETE NECK COVERAGE, AND INDICATE ANEURYSM OCCLUSION RAYMOND AND ROY AS CLASS 3. THE PATIENTS MEDICAL HISTORY INCLUDED CONTROLLED HYPERTENSION. IT WAS REPORTED THAT THE PIPELINE DEVICE WAS SUCCESSFULLY IMPLANTED. PIPELINE ACHIEVED WALL APPOSITION AND THERE WAS OPHTHALMIC SIDE BRANCHES THAT COVERED BY THE PIPELINE. THERE WAS NO DEVICE FLATTENING OR DEVICE TWISTING. THE POST-PROCEDURE AE (ADVERSE EVENT) WAS A STROKE ONSET DATE (B)(6) 2025. THE AE DID NOT RESULT IN ANY TREATMENT; HOSPITALIZATION, BLOOD TRANSFUSION, PERCUTANEOUS INTERVENTION, SURGICAL PROCEDURE AND WAS NOT TREATED IN ANOTHER MANNER. THE PATIENT

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304311 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632476 ↗
• 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 PATIENT EXPERIENCED A PERCUTANEOUS KYPHOPLASTY. THIS ADVERSE EVENT (AE) DID NOT LEAD TO HOS PITALIZATION. THE OUTCOME STATUS IS RECOVERED/RESOLVED WITH AN OUTCOME DATE OF (B)(6) 2025. THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE PATIENT UNDERWENT KYPHOPLASTY FOR A MODERATE SUBACUTE COMPRESSION FRACTURE AT T8 WITH A MILD SUBACUTE COMPRESSION FRACTURE AT L2. FRACTURES ARE CONSIDERED RELATED TO SEVERE OSTEOPOROSIS (PRE-EXISTING). THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION, PROCEDURE, OR DEVICE. THE SPONSOR ASSESSMENT WAS "RESULT: YES," THEY ADJUDICATED AS NON-SERIOUS.

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

  MAUDE report 22118404 ↗
• MalfunctionMar 10, 2025Break; Material Frayed; Retraction Problem; Material Deformation; Physical Resistance/Sticking; Break; Material Frayed; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED NO PRU LEVEL WAS NOTED FROM NURSING STAFF. MEDICAL HISTORY ANXIETY, TOBACCO ABUSE, HLD, PSORIASIS, METH USED IN THE PAST(20) YRS AGO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21563728 ↗
• MalfunctionMar 6, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation Failure; Activation, Positioning or Separation Problem; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, A PATIENT WITH A LEFT INTERNAL CAROTID ARTERY (LICA) ANEURYSM, SPONTANEOUS SUBARACHNOID HEMORRHAGE (SAH), SUDDEN ONSET HEADACHE, AND HYPERTENSION UNDERWENT TREATMENT. THE ANEURYSM WAS UNRUPTURED AND SACCULAR, WITH A MAXIMUM DIAMETER AND NECK DIAMETER OF 4 MILLIMETERS. THE LANDING ZONE MEASURED 3.5 MILLIMETERS DISTALLY AND 4.25 MILLIMETERS PROXIMALLY, WITH MODERATE VESSEL TORTUOSITY. POST-PROCEDURE IMAGING REVEALED A SINGLE WIRE PROTRUDING INTO THE PARENT VESSEL AT THE PROXIMAL END, AS SEEN ON DYNA COMPUTED TOMOGRAPHY. ADDITIONALLY, A SINGLE PLATINUM WIRE WAS BENT TOWARD THE CENTER OF THE INTERNAL CAROTID ARTERY IN THE PATH OF BLOOD FLOW. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, WITH A PLATELET REACTIVITY UNIT LEVEL OF 100. THE DEVICE DEPLOYMENT WAS UNEVENTFUL WITH GOOD WALL APPOSITION EXCEPT AT THE PROXIMAL END. A J-WIRE TECHNIQUE WAS USED TO IMPROVE APPOSITION, AND FOLLOW-UP ANGIOGRAPHY SHOWED SATISFACTORY RESULTS. DESPITE THE IMAGING FINDINGS, THE PHYSICIAN DECIDED AGAINST FURTHER INTERVENTION SUCH AS BALLOON ANGIOPLASTY. THE PATIENT IS CURRENTLY DOING WELL WITH NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21537222 ↗
• MalfunctionMay 20, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON THE DEVICES DID NOT OPEN WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355205 ↗
• MalfunctionMar 6, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION HAS BEEN RECEIVED REPORTING THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THERE WAS NO DAMAGE TO THE PIPELINE PUSH WIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18847235 ↗
• MalfunctionFeb 27, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING PIPELINE EMBOLIZATION FOR TREATMENT OF MULTI LOBULAR PARA OPHTHALMIC, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.8 MM AND PROXIMAL: 4.4 MM. THE ACCESSED VESSEL WAS THE RIGHT M1 WITH A DIAMETER OF 3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 96. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A SUCCESSFUL IMPLANT. IT WAS REPORTED THAT THE PIPELINE WAS ADVANCED THROUGH THE PHENOM 27 DISTAL TO THE ANEURYSM. DEPLOYMENT COMMENCED. DISTAL BRAID OPENED WELL AND WAS PLACED AT THE DISTAL LANDING ZONE. SEVERAL MM WERE DEPLOYED SUCCESSFULLY. ABOUT 50% OF DEVICE WAS DEPLOYED WHEN THE BRAID REMAINED CONSTRAINED. THE DOCTOR RESHEATHED TWICE WITH THE SAME RESULT. HE LOADED AND UNLOADED THE DEVICE THE BRAID REMAINED CONSTRAINED. THE BEHAVIOR OF THE BRAID WAS CONCERNING AND THE ENTIRE SYSTEM WAS REMOVED FROM THE BODY. A NEW PHENOM 27 AND DIFFERENT DEVICE (SAME SIZE DIFFERENT LOT) WAS USED. THIS WAS IMPLANTED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793706 ↗
• MalfunctionFeb 14, 2024Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE BREAK WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705971 ↗
• InjuryJan 25, 2024Structural Problem; Adverse Event Without Identified Device or Use Problem; Structural Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT'S PROLONGED HOSPITALIZATION WAS DUE TO RETREATMENT. MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT TARGET TREATED ANEURYSM RETREATMENT ONSET DATE 2023-11-30. THE RETREATMENT RESULTED IN NEW HOSPITALIZATION (ICU) FROM 2023-11-30 TO 2023-12-01. A SECOND PIPELINE DEVICE (LOT B561271) WAS PLACED INTO ORIGINAL. THE ANEURYSM WAS STILL FILLING AND THE PATIENT WAS EXPERIENCING BRUISING DUE TO DUAL ANTIPLATELET THERAPY (DAPT). THE TREATING PHYSICIAN DECIDED TO RETREAT THE ANEURYSM SO THAT THEY COULD STOP DAPT. THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING PER THE SITE. THE PATIENT RECOVERED AND THE ISSUE RESOLVED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, LEFT INTERNAL CAROTID ARTERY (ICA) C7 SIDE BRANCH ANEURYSM WITH A MAX DIAMETER OF 7MM AND A 4MM NECK DIAMETER. THE ANEURYSM DOME HEIGHT WAS 7MM AND WIDTH 4MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM WAS 3.8MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM WAS 4.1MM. THERE WAS NO STASIS AT THE END OF THE PROCEDURE. THERE WAS COMPLETE NECK COVERAGE AT THE END OF THE PROCED

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

  MAUDE report 18583905 ↗
• MalfunctionApr 18, 2023Break; Unintended Ejection; Physical Resistance/Sticking; Break; Unintended Ejection; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK AT THE HUB AND THE TIP COIL OF THE DEVICE FRACTURED OFF. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE PARA OPHTHALMIC WITH A MAX DIAMETER OF 4.75MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 4.35MM DISTALLY AND 4.50MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND PRU LEVEL WAS WITHIN ADEQUATE RANGES. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS TECHNICAL SUCCESS. THERE WAS SOME VASOSPASM AT THE END OF THE CASE THAT CLEARED AFTER WAITING A FEW MINUTES. IT WAS REPORTED THAT UTILIZING THE TRIAXIAL SYSTEM OF BMX81, ESPERANCE, AND PHENOM 27, THE DOCTOR SUCCESSFULLY DEPLOYED PED2-450-14 IN THE LEFT ICA AND WANTED TO PLACE ANOTHER DEVICE ACROSS THE NECK OF THE ANEURYSM. WHILE LOADING PED2-450-12 INTO THE PHENOM 27, THE PHYSICIAN FELT RESISTANCE AS HE ADVANCED THE DEVICE THROUGH THE PHENOM 27 CATHETER. THE DECISION WAS MADE TO ATTEMPT TO RESHEATH THE DEVICE OUT OF THE PHENOM 27, HOWEVER THE STENT DEPLOYED INTO THE HUB OF THE PHENOM 27 CATHETER. THE DOCTOR WAS ABLE TO REMOVE THE STENT FROM THE HUB UTILIZING

  Patient problems: Vasoconstriction

  MAUDE report 16761229 ↗
• MalfunctionMar 9, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 6 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.7 MM DISTALLY AND 5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 196. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED A NEW DEVICE PLACED WITH NO ISSUES. IT WAS REPORTED THAT THE PIPELINE WAS OPENED IN THE M1 THEN BROUGHT TO DISTAL LANDING ZONE. DEVICE WAS OPENED ACROSS NECK OF ANEURYSM AND BROUGHT TO PROXIMAL LANDING ZONE. WHEN MD TRIED TO DEPLOY THE PIPELINE, IT DID NOT COME OFF THE DELIVERY WIRE. DEVICE WAS RESHEATHED AND MICRO CATHETER AND DEVICE WERE REMOVED. WE ATTEMPTED TO DEPLOY DEVICE ON THE BACK TABLE, BUT THE PIPELINE STILL DID NOT COME OFF DELIVERY WIRE. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513749 ↗
• MalfunctionDec 15, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. DISTAL SECTION WOULD NOT OPEN. RECAPTURED 3 TIMES AND IT HAD THE "TULIP" LOOK TO IT. THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITION STEPS WERE TAKEN TO OPEN THE PIPELINE. IT WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN SACCULAR, UNRUPTURED ANEURYSM IN THE CAVERNOUS LOCATION. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. THE DISTAL LANDING ZONE WAS 4.2MM AND THE PROXIMAL LANDING ZONE WAS 4.5MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATLET TREATMENT WAS ADMINISTERED. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15993226 ↗
• MalfunctionDec 7, 2022Positioning Failure; Activation Failure; Positioning Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS A SERIOUS ADVERSE DEVICE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936932 ↗
• MalfunctionDec 2, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE FAILURE TO OPEN IN THE MIDDLE SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.5 MM AND A 3.4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.25 MM DISTALLY AND 4.07 MM PROXIMALLY.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL IS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS ADEQUATE. IT WAS REPORTED THAT PED2-450-12 BEGAN TO PARTIALLY DEPLOY IN STRAIGHT SEGMENT, BUT FAILED TO DEPLOY AROUND THE GENU. AFTER MULTIPLE ATTEMPTS TO TROUBLESHOOT UTILIZING TECHNIQUES SUCH AS "WAGGING," THE DOCTOR DECIDED TO REMOVE THE PED2-450-12 FROM THE BODY AND DOWNSIZED THE DEVICE TO PED2-375-12, WHICH OPENED WITHOUT PROBLEM. PATIENT WAS UNHARMED AND TECHNICAL SUCCESS WAS ACHIEVED. IT WAS REPORTED THAT THE PIPELINE FAILED TO OPEN IN THE MIDDLE SECTION. THE PIPELINE WAS POSITIONED IN A BEND IN THE MIDDLE SEGMENT. THE PIPELINE HAD BEEN DEPLOYED MORE THAN 50% WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906881 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED2 PIPELINE STENTS FAILED TO OPEN. 7 FR. RIST GUIDE PLACED IN CAVERNOUS LEFT INTERNAL CAROTID ARTERY (ICA) AND 4.50X20 PIPELINE SHIELD DELIVERS VIA SUPPORT OF PHENOM PLUS INTERMEDIATE CATHETER AND PHENOM 27 150 CM DELIVERY MICROCATHETER. PIPELINE OPENED DISTALLY WITHOUT ISSUE AND OPPOSED WELL ACROSS ANEURYSM THE PROXIMAL 6 MM OF THE PED2-450-20 COULD NOT OPEN AT A SECTION OF THE LICA WHICH RE-LOOKING AT THE PREVIOUS CT THERE WAS A TIGHT KINK THE PIPELINE COULD NOT OVERCOME DESPITE NUMEROUS ATTEMPTS TO OVERCOME VIA ¿WAGGING¿ TECHNIQUE AND RESHEATH LUNG ATTEMPTS. FINALLY, PHYSICIAN DECIDED TO REMOVE PIPELINE AND ATTEMPT WITH NEW PIPELINE SHIELD 4.50X20. THE PROXIMAL SECTION WAS POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN A CAPTURE COIL 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 PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE FIRST PIPELINE FAILED TO OPEN IN THE PROXIMAL SECTION. THE SECOND FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS SUCCESSFULLY TREATED WITH SHORTER LENGTH PIPELINE SHIEL

  Patient problems: Headache; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 15200714 ↗
• MalfunctionMay 24, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THREE PIPELINES FAILED TO OPEN DISTALLY. THE PHYSICIAN HAD ATTEMPTED TO DEPLOY MULTIPLE DEVICES, BUT THE DEVICES WOULD NOT OPEN DISTALLY DESPITE MULTIPLE ATTEMPTS OF PUSHING THE DEVICE, UNSHEATHING THE DEVICE, AND COMBINATIONS THEREOF. THE MIDDLE OF THE PIPELINES HAD BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THE FAILED TO OPEN. THE PATIENT'S HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PATIENT RECEIVED STENT-ASSISTED COILING, AND DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ICA. THE MAX DIAMETER AND NECK DIAMETER WERE ~6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 10MM DISTAL AND 10MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14489433 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A PATIENT HAD 3 STROKES AFTER HAVING A PIPELINE DEVICE IMPLANTED.

  Patient problems: Stroke/CVA

  MAUDE report 14174341 ↗
• MalfunctionApr 11, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 PIPELINE FLEX WITH SHIELD DEVICES THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER IMPLANTATION TO TREAT AN UNRUPTURED SACCULAR OPHTHALMIC ARTERY SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; PRU LEVEL WAS 25. IT WAS REPORTED THAT THE PIPELINE DEVICES AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). WHILE ATTEMPTING TO DEPLOY BOTH PIPELINES THE DISTAL END WOULD NOT OPEN. THE FIRST PIPELINE (MODEL: PED2-450-12, LOT: B311431) WAS RESHEATHED 3 TIMES AND ON THE THIRD TIME RESHEATHING, THE PIPELINE BECAME STUCK IN THE MIDDLE OF THE PHENOM MICROCATHETER. IT WAS CONSIDERED THAT THE PIPELINE MAY HAVE COME OFF THE RESHEATHING PAD. THE SECOND PIPELINE (MODEL: PED2-475-12, LOT: B316802) ALSO FAILED TO OPEN AT THE DISTAL END AND WAS RESHEATHED 2 TIMES WITHOUT OPENING SUCCESSFULLY. IT WAS NOTED THAT MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR DEVICES WERE TRIED TO OPEN THE PIPELINES. THE PIPELINE WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075596 ↗
• MalfunctionMar 30, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE MIDDLE 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 WERE NO ADDITIONAL STEPS REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. A DAPT WAS ADMINISTERED AND THE PRU WAS WITHIN EXPECTED LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED ALL VASCULATURE WAS THE SAME AS BASELINE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5.2MM AND A 4.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956160 ↗
• MalfunctionJan 25, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ICA. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.25MM DISTAL AND 4.4MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 15. IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY THE PIPELINE, THE DISTAL END WAS NOT OPENING. AFTER 2 ATTEMPTS THE DEVICE WAS REMOVED AND A SECOND DEVICE OF THE SAME SIZE WAS SUCCESSFULLY DEPLOYED AFTER RESHEATHING TWICE. THE PHYSICIAN COMMENTED THAT THE TORTUOSITY OF THE DISTAL VESSEL WAS NOT APPRECIATED AND THAT IS PROBABLY WHY THE FIRST DEVICE DIDN'T OPEN RIGHT AWAY. THE DISTAL END OF THE PIPELINE WAS POSITIONED IN A BEND, AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED 2 OR LESS TIMES. NO ADDITIONAL STEPS OR DEVICES WERE USED TO TRY TO OPEN THE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE VERY GOOD. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343405 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT ON (B)(6) 2021, A PIPELINE FLEX WITH SHIELD (MODEL: PED2-450-20, LOT: B209283) WAS BEING IMPLANTED IN ATTEMPTS TO TREAT 2 UNRUPTURED SUPRACLINOID LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSMS. AFTER THE PIPELINE WAS DELIVERED, THERE WAS SOME FORESHORTENING RESULTING IN INCOMPLETE NECK COVERAGE OF THE MORE DISTAL ANEURYSM. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE TIP OF THE CATHETER WAS NOT MOVED DURING DEPLOYMENT. THE PIPELINE DID NOT JUMP DURING DEPLOYMENT BUT MISSED THE LANDING ZONE. A SECOND, SHORTER PIPELINE FLEX WITH SHIELD (MODEL: PED2-450-12, LOT: B208340) WAS THEN PLACED DISTALLY IN THE PROXIMAL M1 FOR FULL COVERAGE. BOTH DEVICES OPENED WELL WITH GOOD APPOSITION SEEN IN FINAL ANGIO. THE PATIENT WAS PRESCRIPT DUAL ANTIPLATELET TREATMENT (DAPT) - ASPIRIN AND BRILLINTA. 2 DAYS AFTER DISCHARGE, THE PATIENT BEGAN EXPERIENCING STROKE SYMPTOMS AND WAS READMITTED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO INTENSIVE CARE (ICU) AND A THROMBECTOMY WAS DONE. OCCLUSION RECURRED ON (B)(6) 2021 AND ANOTHER THROMBECTOMY WAS SUCCESSFULLY PERFORMED.

  Patient problems: Ischemia; Thrombosis/Thrombus; Unspecified Nervous System Problem

  MAUDE report 12461557 ↗
• MalfunctionJul 21, 2021Activation Failure; Activation Failure

  IT WAS REPORTED THAT 2 PIPELINES WERE ALREADY DEPLOYED IN THE TARGET VESSEL, AND A 3RD PIPELINE WAS DEPLOYING WELL UNTIL ABOUT ONLY 2MMS WERE LEFT IN THE CATHETER. AT THAT POINT, THE PIPELINE WAS STUCK AT THE DISTAL SECTION OF THE MICROCATHETER AND COULD NOT BE DEPLOYED OR RESHEATHED. THE PIPELINE AND MICROCATHETER WERE REMOVED TOGETHER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SOLUTION. THE PHYSICIAN DID RELEASE THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE; HOWEVER, THE ISSUE DID NOT RESOLVE. THERE WAS NO CATHETER OR PUSHWIRE DAMAGE. WITH A NEW PHENOM MICROCATHETER, THE REPORTED PIPELINE WAS BROUGHT TO THE TARGET VESSEL. ONCE THE PTFE SLEEVES WERE RELEASED, AFTER UNSHEATHING A FEW MILLIMETERS OF THE DEVICE, THE PHYSICIAN IMMEDIATELY RECOGNIZED THE PIPELINE WAS FAILING TO OPEN. THE VERY DISTAL END OF THE PIPELINE WAS FLOWERING AND A PINCHED WASTE JUST PROXIMAL TO THE FLOWERING. THE PIPELINE WAS NOT 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 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12206823 ↗
• MalfunctionJul 13, 2020Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ON DAY TWO POST-OP, STENOSIS IN THE IMPLANTED SECOND STENT WAS NOTED. THE SURGEON SUCCESSFULLY RETRIEVED THE CLOT. ON DAY THREE, THE PATIENT'S STATUS WAS IMPROVING WITH ONLY SLIGHT WEAKNESS REMAINING. THE PATIENT WAS TREATED WITH STANDARD DUAL ANTIPLATELET TREATMENT (DAPT). THE SURGEON DID NOT BELIEVE THE STENOSIS WAS RELATED TO THE ISSUES WITH THE FIRST STENT. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO RESISTANCE DURING DELIVERY. THE RESISTANCE ONLY OCCURRED WHEN THE PIPELINE BECAME STUCK IN THE MICROCATHETER DURING RETRIEVAL. THE PATIENT IS CURRENTLY IN REHAB WITH MILD STROKE SYMPTOMS ON THEIR LEFT SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10264742 ↗

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