PIPELINE PED-500-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847536019638), received between Mar 13, 2017 and Jun 21, 2021 — classified as 1 death, 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (16 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.

• InjuryJun 21, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT 3 PIPELINE DEVICES WERE LAZY TO OPEN IN THE MIDDLE AND DISTAL SEGMENTS AND WERE RECAPTURE MULTIPLE TIMES WHICH DID NOT RESOLVE THE ISSUE. THE DEVICES WERE REMOVED AND SUBSEQUENT DEVICES USED. THE FOURTH DEVICE WAS USED SUCCESSFULLY BUT WAS ALSO A BIT LAZY TO OPEN, AND THE PROXIMAL END WAS NOT COMPLETELY OPPOSED. AFTER MULTIPLE ATTEMPTS TO CROSS INTO THE DEVICE, IT WAS FOUND THAT A SMALL FISTULA HAD FORMED, SO ANOTHER PIPELINE WAS USED TO COVER THE FISTULA WHICH WAS IMPLANTED SUCCESSFULLY AND PROVIDED A SATISFACTORY RESULT. THE PATIENT WAS UNDERGOING AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 6MM AND A NECK WIDTH OF 4MM. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU AND THE PATIENT'S VESSEL TORTUOSITY WAS NOTED TO BE SEVERE. THE DEVICES WERE PLACED IN A BEND IN THE MIDDLE SECTION DURING DEPLOYMENT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, THE PRU LEVEL WAS UNKNOWN. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED PARTIAL FILLING OF THE ANEURYSM.

  Patient problems: Fistula

  MAUDE report 12036147 ↗
• MalfunctionMay 4, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE WOULD NOT OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4.3MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4MM DISTAL AND 4.75MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 228. IT WAS REPORTED THAT THE DISTAL SECTION OF THE PIPELINE HAD BEEN POSITIONED IN A BEND WHEN IT FAILED TO OPEN. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED AT THE TIME, AND THE DOCTOR TRIED RESHEATHING MORE THAN 2 TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED TO OPEN THE DEVICE. THE PIPELINE WAS REMOVED AND WAS LEFT DEPLOYED WITH THE PHENOM. A REPLACEMENT DEVICE WAS USED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED THE ICA WAS OPEN AND PATENT, AND SOME STASIS IN THE ANEURYSM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BALLAST 90CM SHEATH, NAVIEN .058 GUIDE CATHETER, AND PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773393 ↗
• MalfunctionFeb 10, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED ONLY THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THERE WAS NO DAMAGE TO THE PUSHWIRE, NO FRICTION OR OTHER ISSUES EXPERIENCED DURING DELIVER, AND ALL CATHETERS WERE ON A CONTINUOUS FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307587 ↗
• MalfunctionJan 26, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS THE DISTAL END OFTHE PIPELINE WHICH FAILED TO OPEN. THE PIPELINE WAS PLACED IN A VESSEL BEND AND IT WAS NOTED THAT THE VESSEL WAS VERY TORTUOUS. THE PROXIMAL LANDING ZONE WAS 4.5MM AND DISTAL LANDING ZONE WAS 3.5MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PIPELINE WAS RESHEATHED 3 TIMES. AFTER IMPLANTING THE REPLACEMENT PIPELINE, POST-PROCEDURE ANGIOGRAPHY SHOWED FAVORABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231642 ↗
• MalfunctionOct 30, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ADVANCED THE MICROCATHETER DISTAL TO THE ANEURYSM. UPON UNSHEATHING THE PIPELINE, THE STENT FAILED TO OPEN DISTALLY, BUT IT WAS BEGINNING TO OPEN PROXIMAL TO THE DISTAL END OF THE DEVICE. THE STENT WAS RESHEATHED, AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT AGAIN, BUT THE DISTAL END REMAINED CLOSED AFTER UNSHEATHING 75% OF THE DEVICE. IT WAS DECIDED TO RECAPTURE THE ENTIRE DEVICE AND STOP THE PROCEDURE. THE PHYSICIAN DID NOT WANT TO TRY A NEW DEVICE. IT WAS NOTED THE STENT WAS NOT POSITIONED IN A BEND, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. 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 ANGIOGRAPHY SHOWED THE SAME RESULTS AS THE BASELINE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A SOFIA 5 FR, PHENOM

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10760065 ↗
• MalfunctionOct 23, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PREVIOUS PIPELINE (5X16) STILL HAD A SMALL ANEURYSM AFTER APPROXIMATELY 17 MONTHS. THE DOCTOR ATTEMPTED TO DEPLOY ANOTHER PIPELINE (5X14), BUT THE DISTAL TIP WOULD NOT OPEN AFTER REPEATED RESHEATHING AT THE TARGET LOCATION. DIFFERENT TECHNIQUES OR PUSHING AND PULLING THE WIRE AND MICROCATHETER WERE APPLIED PER TRAINING AND CONSULT WITH THE PIPELINE SPECIALIST. IT WAS NOTED THE PIPELINE WAS NOT POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, AND RESHEATHING WAS DONE MORE THAN TWICE. THE PIPELINE WAS NOT DEPLOYED, AND REMOVED WITH NO ISSUE. ANOTHER STENT WAS USED AND IMPLANTED INSTEAD TO COMPLETE THE PROCEDURE. 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 ANGIOGRAPHY SHOWED NO ISSUES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 55. ANCILLARY DEVICES INCLUDE A NEURON

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10727978 ↗
• MalfunctionOct 5, 2020Activation Failure; Activation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10628691 ↗
• DeathMay 29, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE DEVICE THAT FAILED TO OPEN AT THE PROXIMAL END. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM OF THE LEFT OPHTHALMIC ARTERY. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE DEVICE WAS IMPLANTED AND THE PUSHWIRE CONNECTION WAS LOST. IT WAS THEN DETERMINED THAT THE PROXIMAL END OF THE DEVICE HAD NOT OPENED. THE SURGEON WAS UNABLE TO RETRIEVE OR OPEN THE PIPELINE DEVICE. IN THE DAYS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED COMPLICATIONS AND DIED. ANCILLARY DEVICES: NAVIEN058 GUIDE CATHETER, PHENOM027 MICROCATHETER, ASAHI CHIKAI10 GUIDEWIRE

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 10102599 ↗
• InjuryApr 24, 2020Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SECOND PIPELINE AND THE PHENOM CATHETER HAD BEEN DISCARDED. THERE WAS NOT ANOTHER EPISODE OF EMBOLISM, AND POST-PROCEDURE THE PATIENT WAS GIVEN INTEGRILIN. AS OF (B)(6) 2020, THE PHYSICIAN REPORTED THE PATIENT WAS DOING WELL AND HOME.

  Patient problems: Embolus

  MAUDE report 9995917 ↗
• MalfunctionApr 23, 2020Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE FLEX DEVICES FAILED TO OPEN. IT WAS REPORTED THAT THE DEVICE WAS PLACED IN LEFT M1, PARTIALLY DEPLOYED AND DRAGGED BACK INTO POSITION. THE DISTAL HALF OPENED CORRECTLY AND THEN KINKED IN THE TURN. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT THE MIDDLE SECTION FAILED TO OPEN. IT WAS RESHEATHED MORE THAN TWO TIMES AND THE KINK WOULDN¿T COME OUT. ANOTHER PIPELINE EXPERIENCED THE SAME ISSUE, AND THEY WERE REMOVED WITH THE MICROCATHETER. THE DEVICES WERE NOT REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE PARAOPHTHALMIC SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 5 MM AND THE NECK WAS 4.5 MM. THE LANDING ZONE OF THE ARTERY WAS NOTED TO BE 4.89 MM DISTAL AND 5.1 MM PROXIMAL. THE VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AT A 120 PRU LEVEL. THE PIPELINE AND ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A NAVIEN CATHETER, PHENOM 27, AND SYNCHRO2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9993344 ↗
• MalfunctionFeb 23, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE (PED) FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY SUPRA OPTHALMIC WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE PIPELINE WAS UNSHEATHED APPROXIMATELY 75% AND FAILED TO OPEN IN THE PROXIMAL, DISTAL, AND MIDDLE SECTIONS. THE PHYSICIAN MANIPULATED THE DEVICE SEVERAL TIMES, BUT IT REFUSED TO OPEN AND TOOK THE SHAPE OF A TULIP. IT WAS NOTED THE DEVICE WAS NOT IN A BEND, RESHEATHING WAS DONE 2 OR FEWER TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE PED WAS REMOVED AND REPLACED WITH A NEW ONE. UPON RETRIEVING THE PTFE SLEEVES, THE DISTAL PART OF THE DEVICE APPEARED TO BE DAMAGED. 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. ANCILLARY DEVICES INCLUDE A SYNCHRO II, PHENOM 27, PHENOM PLUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9743256 ↗
• MalfunctionJan 23, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4-5MM, A 5MM NECK DIAMETER, AND A 4.8X5.2MM LANDING ZONE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PIPELINE WAS PLACED AT THE DISTAL END OF THE TARGET VESSEL WITH THE MARKSMAN MICROCATHETER, AND THE PIPELINE WAS RELEASED ACCORDING TO THE OPERATION STANDARD. HOWEVER, THE TIP SIDE COULD NOT BE OPENED. REPEATED ADJUSTMENTS WERE TRIED, BUT THE PIPELINE STILL FAILED TO OPEN. IT WAS THEN WITHDRAWN FROM THE PATIENT AND REPLACED WITH ANOTHER DEVICE TO CONTINUE THE SURGERY. 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. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9622999 ↗
• MalfunctionApr 11, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL END, AND WAS NOT ABLE TO BE RECAPTURED WHEN NEEDED, EVEN AFTER MULTIPLE ATTEMPTS. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, AND IT WAS RESHEATED LESS THAN OR EQUAL TO 2 TIMES. THERE PIPELINE WAS REMOVED FROM THE PATIENT USING A CORKING TECHNIQUE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 4MM AND A NECK DIAMETER OF 3MM. VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED BUT THE PRU LEVEL WAS UNKNOWN. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU, NOR WERE THEY PLACED IN A BEND. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8506496 ↗
• MalfunctionMar 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE DISTAL END WOULD NOT OPEN. THE DEVICE WAS RESHEATHED 2 TIMES. IT WAS NOTED THE PROXIMAL AND MIDDLE PART OF THE DEVICE WAS POSITIONED IN A BEND. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE DEVICE. THE PHYSICIAN DECIDED TO USE A NEW ONE. THE DEVICE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM AT THE RIGHT OPTHALMIC WITH A MAX DIAMETER OF 6MM AND A NECK DIAMETER OF 3MM. THE DISTAL AND PROXIMAL LANDING ZONES WERE 4.5MM AND 4.9MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THE POST PROCEDURE ANGIOGRAPHIC RESULT WAS VERY GOOD. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8388614 ↗
• MalfunctionAug 30, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL EDGE OF THE PIPELINE WAS NOT OPENING AND APPEARED TRUMPETED DESPITE 3 RESHEATHINGS. AS A RESULT THE DEVICE WAS REMOVED AND THE PATIENT SUCCESSFULLY TREATED WITH ANOTHER PIPELINE DEVICE. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR, 10MM RIGHT PARAOPTHALMIC ANEURYSM THROUGH A MODERATE VESSEL TORTUOSITY. IT WAS NOTED THAT THE VESSELS HAD A LARGE DIAMETER AND THAT THE DEVICE WAS NOT POSITIONED IN A BEND. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED BUT THEPRU LEVEL WAS UNKNOWN. POST ANGIOGRAPHIC RESULT SHOWED STASIS. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO PATIENT SYMPTOMS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832723 ↗
• MalfunctionMar 13, 2017Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT A PIPELINE FLEX DEVICE DID NOT OPEN ON THE DISTAL EDGE DURING A PROCEDURE. THE DEVICE WAS RESHEATHED AND RE-DEPLOYED MULTIPLE TIMES, WHICH DID NOT RESOLVE THE ISSUE. THE DEVICE WAS REMOVED AND DISCARDED BY THE CUSTOMER. THERE WERE NO REPORTS OF PATIENT INJURY IN CONNECTION WITH THIS EVENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX. DIAMETER WAS 6MM AND NECK DIAMETER WAS 4MM. THE DISTAL LANDING ZONE WAS 4.8MM AND THE PROXIMAL LANDING ZONE WAS 5.0MM. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6401597 ↗

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-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-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-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