PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000284510), received between Apr 19, 2021 and Apr 28, 2025 — classified as 5 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2025Structural Problem; Material Twisted/Bent; Activation Failure; Structural Problem; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE CAUSE OF THE EVENT AND IT WAS DEEMED THAT THE CAVERNOUS AND OPHTHALMIC SEGMENTS OF THE INTERNAL CAROTID ARTERY (ICA) WERE TOO TORTUOUS TO DEPLOY A PIPELINE DEVICE. THE DEVICE DID NOT HAVE THE ABILITY TO OWN AROUND THE BENDS DESPITE SIGNIFICANT MANIPULATION. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921008 ↗
• MalfunctionFeb 25, 2025Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Activation, Positioning or Separation Problem; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER FURTHER DISCUSSING THE CASE WITH THE PERFORMING PHYSICIAN, THEY FELT THE CAUSE OF THE FAILURE TO OPEN/DAMAGE/RESISTANCE WAS THAT IT WAS DUE TO THE CATHETER BINDING UP SECONDARY TO A VERY TORTUOUS INTERNAL CAROTID ARTERY AND DID NOT FEEL IT WAS A ¿DEVICE FAILURE.¿ CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE OR CATHETER. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464587 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DISCHARGED TO HOME/SELF-CARE. CHEST COMPRESSIONS GIVEN BRIEFLY AS SUBJECT WOKE UP FROM VAGAL MEDIATED BRADYCARDIA.

  Patient problems: Bradycardia

  MAUDE report 20207664 ↗
• MalfunctionJul 11, 2024Stretched; Material Deformation; Activation Failure; Stretched; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT SEVEN PIPELINES FAILED TO OPEN DISTALLY AND BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE LANDING ZONE WAS 4MM DISTAL AND 5MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS SAID TO BE 80. IT WAS REPORTED THAT THE PHYSICIAN TRIED WITH MULTIPLE PIPELINES IN VARIOUS SIZES, BUT THE SEVERE TORTUOSITY WAS CAUSING THE DEVICES TO STRETCH AND BE UNABLE TO DEPLOY TO THE PHYSICIAN'S STANDARD. THEY WERE FINALLY ABLE TO OPEN A PIPELINE DISTALLY AND DRAG IT INTO PLACE, ALLOWING FOR THE DEVICE TO OPEN AND TREAT THE PATIENT SUCCESSFULLY. THE ENTIRETY OF THE PIPELINES HAD BEEN PLACED IN A BEND WHEN THEY FAILED TO OPEN. THE PIPELINES HAD BEEN RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICES. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE LAST 4 PIPELINES FAILED TO OPEN. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THAT THE PATIENT WAS TREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721785 ↗
• MalfunctionMay 20, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED ICA ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS WERE UNKNOWN. THE LANDING ZONE (ARTERY SIZE) WAS DISTAL 3.26 MM AND PROXIMAL 4.53 MM. THE VESSEL TORTUOSITY WAS MODERATE.  THE HEALTHCARE PROVIDER WAS DEPLOYING THE PIPELINE PROXIMAL TO THE PCOM AND THE DEVICES WOULD NOT OPEN. THEY TRIED MULTIPLE TECHNIQUES SUCH AS WAGGING, LOADING, ETC. THE DEVICE WOULD OPEN IN THE MID SECTION BUT NOT DISTALLY. BOTH DEVICES WERE REMOVED. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. IT WAS UNKNOWN IF DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD, THE HEALTHCARE PROVIDER WENT TO A 4.25-14 PIPELINE. THERE WERE NO PATIENT SYMPTOMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355201 ↗
• MalfunctionApr 3, 2024Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A BALLOON WAS USED TO IMPROVE WALL APPOSITION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS DEPLOYED CENTERED OVER THE ANEURYSM AND EXCELLENT WALL APPOSITION WAS ACHIEVED. THERE WAS SOME IMMEDIATE STASIS IN THE ANEURYSM DOME ON THE CONTROL RUN THROUGH THE GUIDE CATHETER IN THE INTERNAL CAROTID ARTERY. THE MICROCATHETER WAS THEN READVANCED OVER THE DEVICE WIRE AND THE DISTAL COIL LOOP WAS RECAPTURED AND PULLED BACK THROUGH THE DEVICE AND INTO THE PHENOM. THE STENT DID NOT FULLY DEPLOY IN THIS DISTAL SEGMENT EVEN AFTER WIRE MANIPULATION AND TO REMEDY THIS UNDER HIGH MAGNIFICATION FLUOROSCOPIC ROADMAP CONTROL, A 4M X 7MM TRANSFORM OCCLUSION BALLOON CATHETER WAS ADVANCED OVER A 0.014" SYNCRO-2 SOFT MICROWIRE INTO THE LEFT ICA, ACROSS THE NECK OF THE ANEURYSM AND COMPLETE WALL APPOSITION WAS ACHIEVED USING INFLATION FOR A FEW SECONDS. THE SITE RESPONDED THAT PER INVESTIGATOR ¿IT¿S NOT THAT IT DIDN¿T OPEN - I JUST DIDN¿T LIKE THE WALL APPOSITION AND WANTED TO IMPROVE ON THAT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19034538 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID HAVE A CTA ON (B)(6) TO VERIFY OCCLUSION. BY THE TIME THEY GOT TO ANGIO AND AFTER TENECTEPLASE (TNK) THERE WAS RESOLUTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18068577 ↗
• MalfunctionSep 26, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT FULLY OPEN. THE PIPELINE WAS REMOVED AND IT WAS CLEARLY CRIMPED DISTALLY ON THE DEVICE. A NEW DEVICE WAS INSERTED AND SUCCESSFULLY IMPLANTED. THE PIPELINE WAS POSITIONED IN A BEND AT THE DISTAL END. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THE PIPELINE WAS NOT USED FOR AN OFF-LABEL USE. THE PIPELINE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.5MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 3.8MM DISTALLY AND 4.4MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822469 ↗
• MalfunctionSep 12, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE SITE REPORTED 1 DEVICE DEFICIENCY. HOWEVER, AFTER REVIEWING THE SUBJECTS CRF THE SITE MARKED THAT THE RIST RADIAL ACCESS GUIDE CATHETER DID NOT PROVIDE ADEQUATE NAVIGABILITY. FURTHERMORE, THE SITE STATED WALL APPOSITION WAS NOT ACHIEVED AND DEVICE FLATTENING OCCURRED. DEVICE DEFICIENCY CRF STATES THAT THE DEVICE DID NOT OPEN DISTALLY AND PROXIMALLY. IT NEEDED BALLOON ANGIOPLASTY. THE DEVICE FLATTENED DISTALLY. THE BALLOON WAS USED TO IMPROVE WALL APPOSITION. THE OPHTHALMIC SIDE BRANCHES WERE COVERED BY THE PIPELINE DEVICE. THERE WERE 3 DEVICE CRF PAGES COMPLETE 2/3 HAD THE SAME DEVICE REPORTED. ONE WITH A DEVICE DEFICIENCY STATING "DEVICE SLIPPED OFF RESHEATHING PAD AND WAS REMOVED TOGETHER WITH MICROCATHETER." THE SAME DEVICE WAS ALSO REPORTED TO NOT HAVE ACHIEVED WALL APPOSITION AND DEVICE FLATTENING OCCURRED. THIS DEVICE HAD A DEVICE DEFICIENCY REPORTED OF FAILURE TO OPEN. THE REASON NOT IMPLANTED WAS LISTED AS "DEVICE DEFICIENCY". THE SITE WAS QUERIED ON 15-AUG-2023 TO CLARIFY IF IMPLANT WAS SUCCESSFUL, WALL APPOSITION ACHIEVED, AND IF A THIRD DEVICE WAS USED SINCE 2 DEVICE CRF HAD THE SAME DEVICE NOTED. SITE WAS ALSO QUERIED TO CLARIFY IF B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17733000 ↗
• MalfunctionAug 11, 2023Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER. ADDITIONAL STEP TAKEN IN ATTEMPT TO OPEN THE PIPELINE INCLUDED RESHEATHING AND REDEPLOYMENT AFTER IT TRUMPETED BUT AFTER THE SECOND OCCURRENCE THE PHYSICIAN REMOVED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17509169 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION, CAUSALLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. THE STENOSIS DEGREE WAS GREATER THAN 50%.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17410272 ↗
• MalfunctionJun 30, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. DURING THE DEPLOYMENT OF A 4.5X14MM PIPELINE SHIELD THE DISTAL END OF THE DEVICE WOULD NOT OPEN. THERE WERE MULTIPLE ATTEMPTS TO GET THE DISTAL END OF THE DEVICE TO OPEN BY PUSHING WIRE AND FLIPPING THE PTFE SLEEVES, ALL WERE UNSUCCESSFUL. THE PHYSICIAN DID NOT LIKE THE WAY THE PIPELINE WAS DEPLOYING SO HE DID NOT DEPLOY IT AND SUCCESSFULLY REMOVED IT FROM THE PATIENT. A NEW DEVICE WAS SUCCESSFULLY PLACED. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE RIGHT OPTHALMIC ARTERY. VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOSM OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES:  MEDTRONIC PHENOM PLUS FG19120-1030-1S LOT 225702172 CATHETER, ARMADILLO SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238433 ↗
• InjuryJun 29, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WOULD BE SENT TO ANOTHER FACILITY FOR SECOND OPINION/REPEAT TREATMENT. THERE WERE NO ADDITIONAL INTERVENTIONS REQUIRED DUE TO THE ABORTION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226009 ↗
• MalfunctionMay 22, 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 LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 9 MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.8 MM DISTALLY AND 4.3 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 125. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED SUCCESSFUL FLOW DIVERSION. IT WAS REPORTED THAT THE PHYSICIAN DISCARDED 2 PIPELINES BECAUSE WASN'T COMFORTABLE DEPLOYING IN THAT LOCATION. PIPELINES FISH MOUTHED SLIGHTLY IN PATIENT BUT OPENED AS NORMAL ON BACK TABLE. PHYSICIAN REPLACED WITH 2 PIPELINES FROM MY TRUNK STOCK THAT DEPLOYED SUCCESSFULLY. IT WAS REPORTED BOTH OF THE PIPELINES FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS POSITIONED IN A DISTAL BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM THE PATIENT BY RESHEATHING AND REMOVING WITH T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973908 ↗
• MalfunctionMay 18, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS PREPARED AS USUAL, MANUAL FLUSH INJECTION, NAVIGATED THROUGH TORTUOUS ANATOMY TO M1, STARTED INITIAL PRE-DEPLOYMENT. IT WAS REPORTED THAT THE PIPELINE DISTAL TIP DID NOT SEEM TO WANT TO OPEN FULLY. TRIED TO RECAPTURE, REPOSITION, AND REDEPLOY AND STILL DISTAL END WOULD NOT OPEN. COULD NOT ADVANCE THE MICROCATHETER BACK OVER THE PTFE SLEEVES TO FULLY RECAPTURE THE PIPELINE. DECISION WAS MADE TO CORK PIPELINE AND REMOVE. NEW PIPELINE WAS USED USING SAME PROCEDURE AND DEPLOYED SATISFACTORILY. 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. 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 INDICATION THAT IS APPROVED (ON-LABEL). THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING ARTERY OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. THE LANDI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953978 ↗
• InjuryMay 9, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE HAD TO BE DONE DUE TO A COMPLICATION FROM A DIFFERENT PROCEDURE REMOVAL OF A TUMOR. ¿ HE'S NOW TRACH'ED AND PEG'ED, SOMETIMES FOLLOWING 1 STEP COMMANDS, RIGHT EYE 3RD NERVE PALSY, LEFT EYE OPENS TO PAIN, SOME LEFT SIDED WEAKNESS. HAD SOME BUMPS DURING HOSPITALIZATION, TEMPORARILY WASN'T WORKING, ETC, BUT GENERALLY HE'S STABLE.".

  Patient problems: Insufficient Information; Muscle Weakness/Atrophy; Pain; Unspecified Nervous System Problem

  MAUDE report 16894779 ↗
• MalfunctionAug 24, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. PIPELINE WAS INITIALLY OPENED IN THE M1 SEGMENT AND DRAGGED BACK TO THE DISTAL LANDING ZONE. PIPELINE WAS OPEN IN THE MIDDLE BUT WOULD NOT OPEN COMPLETELY DISTALLY. IT WAS RECAPTURED 2 TIMES, 2ND TIME ALL THE WAY TO THE DISTAL END OF THE DEVICE. PIPELINE WOULD STILL NOT OPEN. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) CAVERNOUS. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 5MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL LANDING ZONE WAS 9MM. VESSEL TORTUOSITY WAS MODERATE. SUCCESSFUL PIPELINE DEPLOYEDWITH ANOTHER UNIT 4.75 X12. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: INFINITI SHEATH,  GUIDE CATHETER, PHENOM 27 150 MICROCATHETER, SYNCHRO 2 STANDARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289843 ↗
• MalfunctionJul 27, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARA OPHTHALMIC SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.3MM DISTAL AND 4.5MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 65. IT WAS REPORTED THAT THE DOCTOR OBTAINED ACCESS INTO THE RIGHT CAROTID ARTERY WITH A BENCHMARK GUIDE CATHETER. THEY THEN ACCESSED THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH THE PHENOM 027 MICROCATHETER IN PREPARATION FOR PIPELINE DEPLOYMENT. THE DEVICE WAS ADVANCE TO THE DISTAL END OF THE MICROCATHETER, AND THEY PULLED THE PHENOM BACK INTO THE DISTAL INTERNAL CAROTID. THE DOCTOR BEGAN DEPLOYING THE DEVICE. AND DURING DEPLOYMENT THE DISTAL END OF THE PIPELINE OPENED ABOUT 25-30 PERCENT. THEY CONTINUED DEPLOYING THE DEVICE AND THE MIDDLE PORTION OF THE PIPELINE OPENED AND FULLY APPOSED THE VESSEL WALL. THEY HAD HOPED THE DISTAL END WOULD OPEN FULLY AS THEY CONTINUED WITH DEVICE DEPLOYMENT. THIS DID NOT OCCUR, SO THE DEVICE WAS RE-SHEATHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117734 ↗
• MalfunctionJun 1, 2022Activation Failure; Activation Failure

  2022-MAY-24 (B)(4) (REP, HCP): MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE FAILED TO OPEN DISTALLY. DUE TO SEVERE TORTUOSITY AND A HIGH POSTERIOR GENU, THE DEVICE FAILED TO OPEN DISTALLY AND SEEMED TO BE CRIMPED. THE DOCTOR RESHEATHED THE DEVICE TWICE AND THE DISTAL END STILL FAILED TO OPEN. THE DEVICE WAS REMOVED THROUGH THE P27 AND A NEW DEVICE WAS INSERTED AND DEPLOYED SUCCESSFULLY. THE DISTAL PART OF THE PIPELINE WAS POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE HYPOTHESEAL SEGMENT. THE MAX DIAMETER WAS 8.3MM AND THE NECK DIAMETER WAS 2.5MM. THE DISTAL LANDING "ZINE" WAS 3.3MM AND THE PROXIMAL LANDING ZONE WAS 4.66MM. VESSEL TORTUOSITY WAS SEVERE. THE PROCEDURE WAS SUCCESSFUL WHEN A SECOND DEVICE WAS IMPLANTED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14558080 ↗
• MalfunctionFeb 6, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE MIDDLE PORTION OF THE PIPELINE FAILED TO OPEN. THE MIDDLE 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 TWO TIMES. THERE WERE NO ADDITIONAL STEPS REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THE PIPELINE 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE PCOMM WITH A MAX DIAMETER OF 4.5MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. A DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND THE PRU LEVEL WAS 5. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED A GREAT RESULT. ANCILLARY DEVICES INCLUDE: A RIST 079, A PHENOM PLUS, A PHENOM 27, AND A SYNCHRO 14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13467445 ↗
• MalfunctionFeb 1, 2022Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.5MM DISTAL AND 4.7MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 100.  IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY THE PIPELINE, THE DISTAL SEGMENT WOULD NOT OPEN PROPERLY. THE DEVICE WAS RESHEATHED 2 TIMES, AND IT DID NOT LOOK RIGHT AND HAD A "TULIP" LOOK TO IT. THE DOCTOR REMOVED THE PIPELINE AND OPENED IT ON THE TABLE AND IT WAS CRIMPED AT THE DISTAL END. THE DISTAL PART OF THE PIPELINE WAS POSITIONED IN A BEND WHEN IT FAILED TO OPEN, AND LESS THAN 50% HAD BEEN DEPLOYED. NO ADDITIONAL STEPS HAD BEEN TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GREAT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418984 ↗
• MalfunctionAug 29, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE STENT FAILED TO OPEN, AND THE PTFE SLEEVES WOULD NOT RESHEATH INTO THE PHENOM 27 MICROCATHETER. THE DEVICE BECAME LOCKED UP AT THE DISTAL END. THE PHYSICIAN PULLED AS HARD AS THEY COULD, AND THEY STILL WOULD NOT RETRACT. AFTER RELEASING THE LOAD IN THE SYSTEM AND MULTIPLE ATTEMPTS, THE DISTAL END FINALLY OPENED AND THE SLEEVES RELEASED. RESHEATHING HAD BEEN PERFORMED LESS THAN THREE TIMES, AND THE STENT WAS NOT POSITIONED IN A BEND. THE DELIVERY SYSTEM WAS REMOVED WITH NO FURTHER ISSUES TO COMPLETE THE PROCEDURE. FULL WALL APPOSITION HAD BEEN ACHIEVED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED ANEURYSM WITH MODERATE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE A PHENOM PLUS SHEATH, PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381596 ↗
• MalfunctionAug 25, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THERE WAS A PIPELINE FAILURE ON DEPLOYMENT. THE FIRST DEVICE PED2-450-12 WAS PREPPED PER IFU AND TAKEN UP TO MCA AND PARTIALLY DEPLOYED AND DRAGGED INTO POSITION DISTAL TO OPHTHALMIC ARTERY. IT WAS NOTED THAT THERE WERE CHALLENGES GETTING DEVICE TO OPEN BUT AFTER ONE RE-SHEATH ATTEMPT, THEY WERE ABLE TO GET DEVICE TO OPEN AND LAND PROXIMAL TO ANEURYSM IN THE STRAIGHT CAVERNOUS SEGMENT. UPON NAVIGATING FOR RETRIEVAL PROXIMAL SEGMENT OF DEVICE MOVED THUS NEEDING A 2ND DEVICE TO BE PLACED. USED THE PED2-450-14 AND PREPPED PER IFU AND AGAIN OPENED IN MCA AND RE-SHEATHED DEVICE TO PULL INTO DELIVERY POSITION TO OVERLAP FIRST DEVICE. ISSUES AT 3/4 OF THE DEPLOYMENT WHEN NEEDED TO RE-SHEATH, EXTREME FORWARD TENSION WAS EVIDENT AND THEN DEVICE SEEMED TO COME OFF THE RE-SHEATHING PAD AS TIP COIL CAME BACK WITH NO EVIDENCE OF CONTROL OF DEPLOYMENT. IT WAS DETERMINED THAT THE DEVICE COULD NOT BE SAFELY SALVAGED THUS RIDING THE STRYKER CAT 5 CATHETER OVER THE PHENOM 27 AND DISTAL PIPELINE DEVICE TO PULL OUT THE ENTIRE SYSTEM. PIPELINE WAS SUCCESSFULLY RETRIEVED OUT OF BODY. THERE WAS A HIGH POS TERIOR GENUE THAT SEEMED TO PLACE ISSUES ON THE DEPLOY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12366946 ↗
• MalfunctionApr 19, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT OPEN IN THE DISTAL SEGMENT. THE MIDDLE SEGMENT OF THE STENT HAD BEEN POSITIONED IN A BEND, MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED, AND RESHEATHING WAS PERFORMED MORE THAN TWICE. A CONTINUOUS FLUSH HAD BEEN USED, AND THERE WAS NO DAMAGE OBSERVED TO THE CATHETER OR PUSHWIRE. AS THE RESHEATHING AND MANIPULATION OF THE DEVICE DID NOT OPEN THE STENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE. HOWEVER, THE STENT BECAME JAMMED IN THE PROXIMAL END OF THE MICROCATHETER. ONCE BOTH DEVICES WERE REMOVED, THE MICROCATHETER WAS CUT OPEN TO ENSURE THE STENT HAD NOT DEPLOYED IN THE GUIDE CATHETER OR ELSEWHERE IN THE SYSTEM. A NEW PIPELINE AND PHENOM 27 WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE DEVICE WAS REMOVED WITH NO ISSUES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A BLISTER-LIKE, RUPTURED ANEURYSM OF THE RIGHT PARA-OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685717 ↗

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-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-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-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