PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-500-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00763000284688), received between Nov 4, 2020 and Dec 8, 2025 — classified as 5 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (60 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 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Device Damaged by Another Device; Activation Failure; Physical Resistance/Sticking; Device Damaged by Another Device; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN AND STENT STUCK ON THE CORE WIRE WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751811 ↗
• MalfunctionNov 7, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.9 MM AND A 6 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.5MM DISTALLY AND 9MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL IT WAS REPORTED THAT DURING DEPLOYMENT, BOTH LARGE SIZED DIAMETER PIPELINES PED STENT WERE VERY DIFFICULT TO OPEN AND WOULD NOT OPEN AT DISTAL END ON BOTH PIPELINE DEVICES. A THIRD PED STENT DEVICE OPEN AND FIT APPROPRIATELY FOR THE PATIENT TO BE TREATED. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN AND WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. 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 SYMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501140 ↗
• MalfunctionSep 4, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CLARIFIED THAT THE DISTAL FLARE AND TRUMPETING IS REFERRING TO THE DISTAL DEVICE NOT OPENING IN A UNIFORM FASHION AND THE DISTAL END APPEARING DAMAGED WHEN REMOVED FROM BODY. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964828 ↗
• MalfunctionJun 17, 2025Material Frayed; Use of Device Problem; Improper or Incorrect Procedure or Method; Component or Accessory Incompatibility; Material Deformation; Activation Failure; Material Frayed; Use of Device Problem; Improper or Incorrect Procedure or Method; Component or Accessory Incompatibility; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN TRYING TO DEPLOY THE PIPELINE, THE DISTAL END OPENED, BUT JUST PROXIMAL TO THE DISTAL END DID NOT OPEN. THE PHYSICIAN TRIED DIFFERENT TECHNIQUES, SUCH AS WAGGING, LOADING, RESHEATHING, AND PULLING CATHETERS TO MID VESSEL, BUT THE PORTION JUST PROXIMAL TO THE DISTAL END DID NOT OPEN. THE VERY DISTAL END STARTED TO LOOK "FRAYED" UNDER FLUORO, SO THE PHYSICIAN REPLACED THE DEVICE. THERE WAS FAILURE TO OPEN IN THE DISTAL AND MIDDLE SECTIONS OF THE PIPELINE. 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 MORE THAN TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE REMOVED FROM PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) , PARAOPHTHALMIC ANEURYSM. THE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22237459 ↗
• MalfunctionMay 2, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN ENDED UP TREATING THE PATIENT WITH A FRED FLOW DIVERTER. THE CASE DATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953454 ↗
• InjuryApr 3, 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 RECEIVED REPORTED THAT CEC ADJUDICATED THE EVENT AS CAUSAL TO PROCEDURE AND POSSIBLE TO DEVICE.

  Patient problems: Failure of Implant; Headache; Stenosis; Thrombosis/Thrombus

  MAUDE report 21766900 ↗
• MalfunctionFeb 3, 2025Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING TWO PIPELINE EMBOLIZATION DEVICES, THERE WAS A FAILURE TO OPEN THE DISTAL SECTION OF THE DEVICES. THE PATIENT HAD AN UNRUPTURED CEREBRAL ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY, CAVERNOUS SEGMENT, WITH A SACCULAR MORPHOLOGY, MEASURING 10MM IN MAXIMUM DIAMETER AND 5MM IN NECK DIAMETER. THE DISTAL ALNDING ZONE WAS 5.11MM AND THE PROXIMAL LANDING ZONE WAS 4.97MM. THE FIRST DEVICE WAS PREPPED PER INSTRUCTIONS FOR USE (IFU) AND ADVANCED TO THE MICRO CATHETER SMOOTHLY. THE INITIAL DISTAL TIP COIL WAS UNHEEDED AS WELL AS THE DISTAL 3 TO 5 MM OF DEVICE WAS DEPLOYED IN ORDER TO EXPOSE THE PTFE SLEEVES, AND THEN THE PHENOM 27 WAS ADVANCED BACK TO THE DISTAL MARKER TO PUSH THE PTFE SLEEVES OUT OF THE WAY. FIRST ATTEMPT TO DEPLOY DEVICE ABOUT 1/3 OF THE DEVICE WAS EXPOSED AND DID NOT OPEN SO THE HEALTHCARE PROVIDER (HCP) CHOSE TO RECAPTURE TO THE DISTAL MARKER AND TRY AGAIN BY PUSHING BRAID TO ADVANCE DEVICE. THIS ATTEMPT ABOUT 50% OF THE DEVICE WAS EXPOSED AND AGAIN THE DISTAL AND REMAINED SHUT. HCP CHOSE TO RECAPTURE AGAIN TO THE DISTAL MARKER AND THEN THIRD ATTEMPT DOCTOR EXPOSED 2/3 OF THE DEVICE AND NOTED THE MIDSECTION OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293477 ↗
• MalfunctionJan 31, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT SUPERIOR HYPOPHYSEAL ARTERY WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. THE LANDING ZONE WAS 3.8MM DISTALLY AND 5.0MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NON-REMARKABLE. IT WAS REPORTED THAT A PIPELINE (PED) AND ALL ACCESSORIES WERE PREPARED PER THEIR RESPECTIVE IFUS. THE PHENOM 27N(P27) WAS ADVANCED OVER THE ARISTOTLE WIRE TO THE M2 SEGMENT AND THE WIRE WAS REMOVED. THE PIPELINE WAS INTRODUCED TO THE P27 AT WHICH TIME THE P27 WAS INTENTIONALLY RETRACTED TO THE M1 SEGMENT. AT THIS POINT THE DISTAL WIRE/PTFE SLEEVES/DISTAL 3-4MM OF THE STENT BRAID WERE UNSHEATHED TO CONFIRM INITIAL OPENING OF THE PED BRAID. IT WAS NOTED THAT THE BRAID WAS "LAZY" AND "SLOW" BUT THERE WAS NO SUSPICION OF DAMAGE TO THE PED BRAID. THE P27 WAS THEN ADVANCED FORWARD TO COVER THE PTFE SLEEVES AND THE SYSTEM WAS RETRACTED TO THE PROXIMAL M1 WHERE THE P27 WAS RETRACTED TO EXPOSE THE DISTAL PED BRAID ONCE AGAIN TO BEGIN PLACING THE PED AT THE DESIRED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282273 ↗
• MalfunctionJan 15, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE INVOLVING A PIPELINE EMBOLIZATION DEVICE, THE DISTAL BRAID OF THE DEVICE WOULD NOT OPEN, AND LESS THAN 50% OF THE DEVICE FAILED TO OPEN. ADDITIONALLY, THE PTFE SLEEVES DID NOT ALLOW FOR RECAPTURE OF THE DEVICE. THE ANEURYSM WAS LOCATED IN THE INTERNAL CAROTID ARTERY BETWEEN THE OPHTHALMIC AND POSTERIOR COMMUNICATING ARTERY, WAS UNRUPTURED, AND HAD A SACCULAR MORPHOLOGY WITH A MAXIMUM DIAMETER OF 5 MILLIMETERS AND A NECK DIAMETER OF 3 MILLIMETERS. THE LANDING ZONE ARTERY SIZE WAS 3.84 MILLIMETERS DISTALLY AND 5 MILLIMETERS PROXIMALLY, WITH MODERATE VESSEL TORTUOSITY. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A SECOND DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160328 ↗
• MalfunctionAug 12, 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 AN AMORPHOUS, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 3 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.8 MM AND PROXIMAL: 4.4 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESSED VESSEL WAS NOTED TO BE 3.8 WITH A DIAMETER OF 4.4 MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 117. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE VANTAGE COVERED THE ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN TRIED TO PLACE THE 5MM PIPELINE AND THE DISTAL END WOULD NOT OPEN AFTER SEVERAL TRIES AND MUCH MANIPULATION. SO, A VANTAGE WAS THEN PULLED AND PLACED SUCCESSFULLY. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. 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. 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 THE MICROCATHETER. A 4.5 X

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960899 ↗
• 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 19721784 ↗
• MalfunctionJun 26, 2024Material Frayed; Material Deformation; Activation Failure; Material Frayed; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED REPORTED THAT A PIPELINE SHIELD THAT COULD NOT BE OPENED DURING DEPLOYMENT DESPITE MULTIPLE DEPLOYMENT ATTEMPTS. WHEN REMOVED, THE DISTAL END OF THE PIPELINE STENT LOOKED VERY FRAYED. IT WAS NOTED THE DEVICE HAD BEEN PREPARED PER IFU. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. IT WAS DETERMINED THE PIPELINE DEVICE WAS DISTAL END WAS PROBABLY ¿MUNTED¿ THE PIPELINE DEVICE WAS REMOVED AND REPLACED WITH NEW PIPELINE WHICH WAS SUCCESSFULLY DEPLOYED. THE ICA ANEURYSM PARAOPTHALMIC LOCATION WIDE NECK WITH MODERATE VESSEL TORTUOSITY. DISTAL END DID NOT OPEN. PIPELINE PLACED IN BEND AT LEVEL OF TERMINUS SECTION OF ICA. RE-SHEATHING WAS ATTEMPTED BUT DETERMINED DUE TO OPENING AGAINST WALL DISTAL TIP OF PIPELINE MAYBE ¿MUNTED¿. THE PIPELINE HAD BEEN RESHEATHED 3 TIMES. NO FRICTION/RESISTANCE OR OTHER ISSUE WERE FELT DURING DELIVERY OR POSITIONING OF THE PIPELINE. DURING DEPLOYMENT OF PED2-500-12 PIPELINE SHIELD DEVICE IN ICA, THE PIPELINE WAS OPENED IN THE TERMINUS SECTION OF THE ICA WITH THE DISTAL PIPELINE UP AGAINST THE VESSEL WALL DISTAL TO THE ANEURYSM. UPON SEVERAL ATTEMPTS TO OPEN THE DISTAL END OF THE PIPELINE WITHOUT SUCCESSES IT WAS DET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615203 ↗
• MalfunctionApr 3, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN DISTALLY.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT PARACLINOID ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3.5MM DISTALLY AND 5.2MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.  DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED AND PRU LEVEL WAS ACT 315. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED 500-14 PIPELINE PLACED WITHOUT ISSUE. IT WAS REPORTED THAT ALL CATHETERS WERE IN PLACE AND STABLE DURING INTRODUCTION OF THE PIPELINE. NO ABNORMAL DIFFICULTY WAS NOTED DURING THIS STEP. THE PHENOM 27 (P27) WAS PLACED DISTALLY INTO THE INFERIOR M2 BRANCH WHEN THE PED WAS INTRODUCED. THE DEVICE WAS THEN UNSHEATHED DISTALLY WHILE STILL IN THE PROXIMAL M2/DISTAL M1. THE DEVICE/P27 SYSTEM WAS THEN PULLED DOWN TO THE ICA TERMINUS/PCOMM SEGMENT. AT THIS POINT THE SYSTEM WAS LOADED AND WIRE PUSH BEGAN. THE DEVICE WAS DEPLOYED THROUGH THE MIDSECTION WHICH OPENED, BUT THE DISTAL END REMAINED SOMEWHAT CONSTRAINED AND IRREGULAR. THERE WAS 1 ATTEMPT TO RE-SHEATH AND REPOSITION THE PED BUT THE IRREGULAR SHAPE REMAINED. IT WAS THEN DECID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032614 ↗
• MalfunctionMar 28, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990763 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PERCUTANEOUS INTERVENTION THE PATIENT UNDERWENT WAS A THROMBECTOMY AND EMBOLIZATION. THE SPONSOR ASSESSED THE EVENT AS CAUSED BY THE DEVICE AND POSSIBLY RELATED TO THE INDEX PROCEDURE AND ANTIPLATELET MEDICATION.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 18990387 ↗
• MalfunctionMar 7, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 4 MM AND A 4 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.5 MM AND PROXIMAL: 5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 140. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE PIPELINE DID NOT OPEN. IT "TRUMPETED" AND COULD NOT OPEN WITH ANY MANIPULATION. SUPPORT WAS HIGH. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. 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. 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 THE MICROCATHETER. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859129 ↗
• MalfunctionMar 6, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852110 ↗
• MalfunctionJan 16, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PIPELINE WAS POSITIONED IN A BEND OF THE DORSAL WALL ANEURYSM RIGHT INTERNAL CAROTID ARTERY. IT WAS NOTED THAT 2/3RD OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 TIMES. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE ANEURYSM TREATED WAS BROAD BASED AND 12MM LENGTH AND 4MM DEPTH. THE CAUSE OF THE FAILURE TO OPEN WAS UNDETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517813 ↗
• MalfunctionNov 15, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT ADMITTED AT THE HOSPITAL WITH HEADACHES. PATIENT EVALUATED BY THE HEALTHCARE PROVIDER (HCP) WHO DETERMINED PATIENT HAD A 22MM LEFT CAROTID TERMINUS ANEURYSM. PATIENT STARTED ON DUAL ANTIPLATELET THERAPY (DAPT) AND 2 DAYS LATER BROUGHT TO ANGIO SUITE FOR PIPELINE EMBOLIZATION. ACCESS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY USING A NEURON MAX 90CM SHEATH. LEFT MIDDLE CEREBRAL ARTERY ACCESSED WITH PHENOM 027 CATHETER AND ARISTOTLE 018 WIRE. PHENOM PLUS PARKED IN COMMUNICATING SEGMENT OF CAROTID ARTERY FOR INTERMEDIATE SUPPORT DURING PROCEDURE. 5.0X10 PIPELINE SHIELD DEVICE SELECTED AND PREPARED PER IFU. PIPELINE DEVICE WAS ADVANCED THROUGH THE PHENOM 027 MICROCATHETER. HCP ATTEMPTED TO DEPLOY DEVICE INTO LEFT MCA. DURING DEPLOYMENT THE DEVICE FAILED TO OPEN ON THE DISTAL END. THE MIDDLE SEGMENT OF THE DEVICE OPENED BUT THE DISTAL DEVICE REMAINED CLOSED. MULTIPLE ATTEMPTS WERE MADE TO RESHEATH AND REDEPLOY DEVICE. THE DEVICE WAS RE-SHEATHED IN PHENOM 027 AND REMOVED FROM PATIENT. A SECOND DEVICE 5.0X12 WAS OPENED AND PREPPED PER IFU. THE SECOND DEVICE ALSO FAILED TO OPEN ON THE DISTAL END IN THE SAME MANNER AS THE FIRST DEVICE. THE DISTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138921 ↗
• MalfunctionNov 14, 2023Structural Problem; Activation Failure; Structural Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132070 ↗
• MalfunctionNov 3, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PIPELINE WAS PLACED IN M1 AND DIDN'T OPEN. IT WAS PLANNED TO DRAG. RE-SHEATHING WAS PERFORMED SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064698 ↗
• MalfunctionOct 26, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT DESPITE PROPER MANIPULATION, DISTAL END OF THE PIPELINE WOULD NOT OPEN. THE PIPELINE WAS PULLED AND DEPLOYED IT ON THE BACK TABLE. EVEN AFTER DEPLOYMENT, A PORTION OF THE PIPELINE WAS STUCK/HUNG UP ON ITSELF (DISTAL 1/3) NOT ALLOWING IT TO EXPAND TO ITS NOMINAL WIDTH. THE PHYSICIAN PLAYED WITH THE PIPELINE AND INSPECTED IT WHICH DID FORCE IT OUT TO ITS NOMINAL 5.25MM WIDTH, BUT VISIBLE INSPECTION WILL ALLOW YOU TO SEE LACK OF SYMMETRY ALONG THE BODY OF THE PIPELINE. ADDITIONALLY IT APPEARED AS THOUGH THE WINGS WOULD NOT SEPARATE FROM THE DISTAL PORTION OF THE PIPELINE. THE PIPELINE WAS NOT POSITIONED IN A BEND AND 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. HE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT PARA OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 3.4MM AND A 2.6MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011983 ↗
• MalfunctionOct 26, 2023Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT WHEN POSITIONING THE PIPELINE TO THE TARGET LANDING ZONE, THE PED JUMPED TOO PROXIMAL AND WAS UNABLE TO BE RE-POSITIONED TO AN IDEAL SPOT. THIS PIPELINE WAS SAFELY REMOVED AND ANOTHER PED (SAME SIZE) WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WAS NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN MOVEMENT OCCURRED AND THERE WASN'T FRICTION OR DIFFICULTY DURING POSITIONING. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE PIPELINE DID JUMP DURING DEPLOYMENT AND THE PIPELINE WAS PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE. 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 RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX D IAMETER OF 7MM AND A 5MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 3.8MM DISTALLY AND 4.7MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AND THE PLATELET RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011401 ↗
• InjuryOct 6, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE DIDN'T OPEN DISTALLY AT FIRST, BUT AFTER SOME ADDITIONAL WAGGING AND PUSHING, THE PIPELINE OPENED AT THE DISTAL END. THE PIPELINE WAS THEN POSITIONED IN THE TARGET WHICH WAS THE TERMINAL INTERNAL CAROTID ARTERY (ICA). THE PIPELINE WAS PUSHED OUT OF THE PHENOM MICROCATHETER AND THE PIPELINE DIDN'T OPEN PROXIMALLY. THE DELIVERY WIRE WAS MANIPULATED BACK AND FORTH TO GET IT TO OPEN BUT IT DIDN¿T' WORK. THE PHENOM MICROCATHETER WAS USED TO BUMP WITH THE PIPELINE AND IT STILL DIDN'T OPEN. THESE MANEUVERS TOOK 30-40 MINUTES AND COULD NOT GET THE PIPELINE TO OPEN PROXIMALLY. THE PIPELINE WAS WITHDRAWN WITH THE PHENOM MICROCATHETER. THE PATIENT HAD A THROMBUS POST PIPELINE REMOVAL. THE PIPELINE WAS POSITIONED IN A BEND AT THE PROXIMAL END. THE PIPELINE WAS MORE THAN 50% 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).   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT CLINOID ANEURYSM WITH A MAX DIAMETER OF 6MM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17886958 ↗
• MalfunctionOct 2, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN DISTALLY AND WOULD NOT RESOLVE AFTER MULTIPLE ATTEMPTS. BOTH WERE REMOVED AND A 4X18 WAS SUCCESSFULLY IMPLANTED. THE PIPELINES WERE POSITIONED IN A BEND IN THE MIDDLE. MORE THAN 50% OF THE PIPELINES WERE DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WERE RESHEATHED MORE THAN 2 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 INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DI AMETER OF 8MM AND A 5MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WAS 3.5MM DISTALLY AND 3.8MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE POST PROCEDURE ANGIOGRAPHIC RESULT SHOWED FULL WALL APPOSITION OF THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858256 ↗

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