PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000284596), received between Nov 3, 2021 and Jun 4, 2025 — classified as 2 injuries, 14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A PIPELINE DEVICE. THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145471 ↗
• MalfunctionMay 12, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED2 PIPELINES FAILED TO OPEN IN THE DISTAL SECTION. THE DOCTOR TRIED TO DEPLOY BOTH THE PIPELINE DEVICES PROXIMAL TO ANTERIOR CHOROIDAL ARTERY BUT THE DISTAL END OF THE DEVICE DID NOT OPEN. TRIED ALL THE DIFFERENT RECOMMENDED MANEUVERS BUT NOTHING HELPED. BOTH DEVICES HAD THE SAME ISSUE BUT THEN DOCTOR SWITCHED TO A COMPETITOR PRODUCT AND IT WAS DEPLOYED SUCCESSFULLY. THE PIPELINES WERE NOT POSITIONED IN BENDS. MORE THAN 50% OF THE PIPELINES HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINES. THE PIPELINES WERE RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THREE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 5MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL LANDING ZONE WAS 4.8MM. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: MIDWAY 43 GUIDE CATHETER, PHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999999 ↗
• MalfunctionDec 10, 2024Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE, AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC INTERNAL CAROTID ARTERY WITH A MAXIMUM DIAMETER OF 5.1 MILLIMETERS AND A NECK DIAMETER OF 4.0 MILLIMETERS WAS BEING TREATED. THE PATIENT HAD SEVERE VESSEL TORTUOSITY. THE PIPELINE EMBOLIZATION DEVICE (PED2-475-12) FAILED TO OPEN IN THE DISTAL SECTION AND BECAME STUCK IN THE PHENOM 27 MICROCATHETER UPON REMOVAL. THEY HAD ATTEMPTED TO REPOSITION THE PIPELINE WITH THE MICROCATHETER IN AN ATTEMPT TO OPEN IT. MORE THAN 50% OF THIS DEVICE WAS DEPLOYED BEFORE THE FAILURE, AND IT WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES BEFORE BEING REMOVED FROM THE PATIENT. THE DEVICE HAD NOT BEEN POSITIONED IN A BEND. ADDITIONALLY, A PIPELINE VANTAGE WITH SHIELD TECHNOLOGY (PED3-027-550-16) FAILED TO OPEN IN THE MIDDLE SECTION. THE DISTAL SEGMENT HAD BEEN POSITIONED IN A BEND. MORE THAN 50% OF THIS DEVICE WAS DEPLOYED, AND IT WAS RESHEATHED MORE THAN TWO TIMES BEFORE REMOVAL. ANOTHER PIPELINE VANTAGE 5X14 WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893480 ↗
• MalfunctionMay 15, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THIS WAS GOING TO BE THE SECOND DEVICE PLACED IN A CONSTRUCT. THE PHYSICIAN OPENED THE DEVICE IN THE M1 SEGMENT. DEVICE WOULD NOT OPEN DISTALLY AND REMAINED CONSTRAINED AFTER SEVERAL ATTEMPTS TO RECAPTURE AND REOPEN. DEVICE WAS BROUGHT BACK AS A SYSTEM TO SEE IF IT WOULD OPEN AND NEVER DID. PHYSICIAN RECAPTURED THE DEVICE AND EXPLANTED AND DEPLOYED IN THE HUB OF THE PHENOM 27. THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. 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 TWO TIMES. 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 CAVERNOUS ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. THE LANDING ZONE WAS 4.7MM DISTALLY AND 5MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320421 ↗
• MalfunctionMay 2, 2024Material Frayed; Activation Failure; Material Frayed; 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 RIGHT INTERNAL CAROTID ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.75 MM AND NECK DIAMETER 3.0 MM. LANDING ZONE (ARTERY SIZE): DISTAL 3.95 MM AND PROXIMAL 4.75 MM. THE VESSEL TORTUOSITY WAS MODERATE. THE HEALTHCARE PROVIDER COULD NOT DEPLOY THE PIPELINE IN THE M1. THE DEVICE WOULD NOT OPEN DISTALLY AND WAS FRAYED. 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 2 TIMES. THE PIPELINE WAS REMOVED FROM PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234772 ↗
• InjuryNov 22, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) ATTEMPTED TO IMPLANT THIS FIRST PIPELINE. THE DISTAL END OF THE DEVICE WOULD NOT OPEN. HCP TRIED RESHEATHING THE PTFE SLEEVES MULTIPLE TIMES AND IT STILL WOULD NOT OPEN. THE MIDDLE PART OF THE PIPELINE WAS 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 TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. HCP WITHDREW THE DEVICE FROM THE PATIENT AND WENT WITH THE NEXT DEVICE. THE HCP TRIED TO TRIED TO DEPLOY THE SECOND PIPELINE AND FAILED DUE TO THE DEVICE NOT OPENING CORRECTLY PROXIMALLY AND THE DEVICE LOOKED DAMAGED, POSSIBLY FROM RESHEATHING, SO THE HCP REMOVED AND WENT FOR A THIRD DEVICE. MORE THAN 50% OF THE SECOND PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE MIDDLE PORTION OF THE PIPELINE WAS POSITION ED IN A BEND. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE HCP ATTEMPTED A THIRD PIPELINE AND IT WOULD ALSO NOT OPEN PROPERLY PROXIMALLY. MORE THAN 50% OF THE THIRD PIPELINE HAD

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

  MAUDE report 18193590 ↗
• MalfunctionSep 12, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE SHIELD STENTS THAT HAD FISH-MOUTHING AT THE DISTAL END DURING DEPLOYMENT. THAT PATIENT WAS UNDERGOING A PROCEDURE FOR TREATMENT OF A RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) PARAOPHTHALMIC SEGMENT BLISTER ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 1MM AND THE NECK DIAMETER WAS 2MM. THE DISTAL LANDING ZONE WAS 3.8MM AND THE PROXIMAL LANDING ZONE WAS 4.89MM. VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED; PRU LEVEL WAS 67. IT WAS REPORTED THAT THE PIPELINES AND ALL ACCESSORY DEVICES WERE PREPARED AND USED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN FIST TRIED TO OPEN THE PIPELINE SHIELD (MODEL: PED2-475-12, LOT: B347741) IN THE DISTAL RIGHT ICA TO COVER THE ANEURYSM. THE DISTAL END OF THE PIPELINE WAS NOT OPENING DESPITE THE MIDDLE AND PROXIMAL SEGMENTS OPENING; THE DISTAL END APPEARED "FISH-MOUTHED." THE PHYSICIAN RESHEATHED THE DEVICE AND ATTEMPTED DEPLOYMENT 2 MORE TIMES BUT THE DISTAL END WAS STILL CRIMPED. IT WAS NOTED THAT MORE THAT 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND. THE PIPELINE WAS RESH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17727990 ↗
• 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 16723834 ↗
• MalfunctionFeb 16, 2023Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE SUSPECTED CAUSE OF THE PIPELINE FAILURE TO OPEN DISTALLY WAS TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385140 ↗
• MalfunctionFeb 10, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 4.3 MM DISTALLY AND 4.6 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT IS UNKNOWN IF DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS REPORTED THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. RESHEATHED 3 TIMES AND COULD NOT GET IT TO OPEN. IT WAS REPORTED THE DISTAL END FAILED TO OPEN. THE DISTAL END 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 MORE THAN TWO TIMES. THERE WAS ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE INCLUDING A WIRE/CATHETER. 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 PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16357611 ↗
• InjuryJan 20, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TWO PIPELINES FAILED TO OPEN IN THE MIDDLE AND DISTAL SECTIONS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3.7MM AT THE DISTAL END AND 4.7MM AT THE PROXIMAL END. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE PRU LEVEL WAS 86. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS THE STENTS WERE OPEN BUT CAPILLARY FILL IN BRAIN WAS MINIMAL DUE TO BRAIN SWELLING AND PRESSURE.  IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED AND THE PROXIMAL END FINISHED IN A TURN. AS A RESULT, THE DISTAL END WOULD NOT OPEN. THE DOCTOR HAD DIFFICULTY RE-ACCESSING THE PROXIMAL END OF THE DEVICE AND SUBSEQUENTLY PULLED OUT THE DELIVERY WIRE OF THE PIPELINE. AFTER SEVERAL ATTEMPTS TO RE-ACCESS THE PROXIMAL END THE DECISION WAS MADE TO TRY AND ACCESS FROM THE GROIN GOING UP THE RIGHT SIDE, THROUGH THE ACOM. A SCEPTER 4X10 BALLOON WAS USED TO OPEN THE PROXIMAL END. SINCE THE DEVICE HAD ENDED IN THE TURN, A SECOND DEVICE WAS IMPLANTED FROM THE RIGHT. A PED2-500-25 DEVICE WAS PLACED FROM

  Patient problems: Intracranial Hemorrhage; Rupture

  MAUDE report 16215749 ↗
• MalfunctionJan 3, 2023Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL ENDS OF TWO PIPELINES FAILED TO OPEN AND LOOKED LIKE A TRUMPET. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT CAVERNOUS ICA. THE MAX DIAMETER WAS 30MM, AND THE NECK DIAMETER WAS 7MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.0MM DISTAL AND 4.4MM PROXIMAL. IT WAS REPORTED THAT THE DISTAL PART OF THE PIPELINES WERE POSITIONED IN A BEND AND LESS THAN 50% HAD BEEN DEPLOYED WHEN THEY FAILED TO OPEN. THE PIPELINES WERE RESHEATHED 2 OR LESS TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE ANEURYSM NECK WAS COVERED WITH NORMAL FLOW IN THE ICA. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PHENOM PLUS GUIDE CATHETER, PHENOM 27 MICROCATHETER, AESTOTLE 24 GUIDEWIRE, AND SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16091764 ↗
• MalfunctionJun 19, 2022Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS POSITIONED PROPERLY AND THE DISTAL SEGMENT WAS BEGINNING TO FLOW OPEN. WHEN ATTEMPTING TO MOVE THE CATHETER AND PED PROXIMAL TO THE APPROPRIATE LANDING ZONE, THE SYSTEM JUMPED PROXIMAL TO THE ANZ. THE PHYSICIAN WAS UNABLE TO NAVIGATE THE PED BACK TO AN APPROPRIATE LOCATION DISTAL TO FULLY COVER THE ANZ NECK. THE PED WAS REMOVED AND A 4.75X14 WAS SUCCESSFULLY IMPLANTED. THERE WAS MOVEMENT DURING PLACEMENT. THERE WERE NOT MULTIPLE PIPELINE DEVICES BEING USED WHEN THE MOVEMENT OCCURRED. THERE WAS MINIMAL FRICTION DURING DELIVERY OR POSITIONING. THE PIPELINE WAS NOT IMPLANTED AT THE INTENDED LOCATION. THE PIPELINE MISSED THE LANDING ZONE. THE DEVICE DID JUMP DURING THE DEPLOYMENT. THE PIPELINE WAS PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE. THE SIDE BRANCH WAS NOT COVERED BY PIPELINE. THE TIP OF THE CATHETER WAS MOVED DURING THE DEPLOYMENT. THE DEVICE WAS NOT USED OFF-LABEL AND 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 RIGHT ICA WITH A MAX DIAMETER OF 8MM AND A 4MM N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741357 ↗
• MalfunctionJun 1, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED3 PIPELINE VANTAGE HAD DIFFICULT PLACEMENT AND WAS NOT ABLE TO BE RESHEATHED. A PED2 PIPELINE SHIELD WAS USED AND WOULD NOT OPEN DISTALLY. WHILE DEPLOYING THE PED3 PIPELINE VANTAGE, TO REPOSITION AND ADJUST, THE HEALTHCARE PROVIDER (HCP) TRIED TO RESHEATH IT, BUT THE DEVICE GOT STIFF AND IT DID NOT ALLOW HIM TO RESHEATH. IT WAS REPORTED AS MOVEMENT DURING PLACEMENT. ONLY ONE PIPELINE WAS BEING USED. THERE WAS SEVERE FRICTION OR DIFFICULTY DURING DELIVERY AND POSITIONING. THE PED3 WAS IMPLANTED AT THE INTENDED LOCATION. THE PED3 MISSED THE LANDING ZONE. A SNARE/RETRIEVAL DEVICE WAS USED. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE PED3 WAS PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE. NO SIDE BRANCHES WERE COVERED BY THE PIPELINE. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT.  THE HCP TRIED TO USE PED2 PIPELINE SHIELD IN THE SAME PATIENT AFTER THE FAILURE OF PED3 PIPELINE VANTAGE, BUT IT DID NOT OPEN DISTALLY EVEN AFTER MULTIPLE TRIES. IT WAS NOT 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 REQUIRED TO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14557895 ↗
• MalfunctionApr 11, 2022Activation Failure; Activation Failure

  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 14075929 ↗
• MalfunctionNov 3, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS NOT OPENING IN A VESSEL BEND WHEN IT FAILED TO OPEN, ALTHOUGH THE PROXIMAL PART OF THE STENT WAS OPENING AROUND A BEND. IT SUCCESSFULLY OPENED PROXIMALLY AROUND THE BEND, BUT WAS UNABLE TO OPEN DISTALLY. THAT IS WHERE IT FORMED THE SHAPE OF A TRUMPET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746227 ↗

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-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-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-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