PIPELINE PED-450-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536016385), received between Nov 28, 2018 and Dec 16, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

1. Jul 13, 2021Class IOpen, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE IN THE MIDDLE SEGMENT OF THE CATHETER DURING DELIVERY OF THE PIPELINE DEVICE. THE ENTIRE SYSTEM WAS WITHDRAWN, AND REPLACEMENT DEVICES WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED A CONTINUOUS FLUSH HAD BEEN USED, AND IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE DEVICES. 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 SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 4.8 MM AND A 3.6 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020948 ↗
• MalfunctionAug 19, 2021Material 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 RIGHT CAVERNOUS SEGMENT. THE MAX DIAMETER WAS 16MM, AND THE NECK DIAMETER WAS 10MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 2.66MM DISTAL AND 4.46MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 160. IT WAS REPORTED THAT THE DEVICE WAS RECAPTURED, AND DEPLOYMENT WAS ATTEMPTED A SECOND TIME IN A TURN. THE DISTAL END WAS UP AGAINST THE VESSEL WALL, AND THE END SEEMED CRIMPED AND WOULD NOT OPEN DESPITE RECAPTURING. THE DISTAL PART HAD BEEN POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED AT THE TIME. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE WAS REMOVED BY PULLING IT THROUGH THE MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED STASIS IN THE ANEURYSM. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A BALLAST SHEATH, NAVIEN GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO 2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342320 ↗
• MalfunctionJul 9, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. IT WAS REPORTED THAT THE DOCTOR DOES NOT RECALL THE TIP OF THE CATHETER BEING UNDER STRESS WHEN THE CATHETER JUMPED. NO ADDITIONAL PIPELINE OR OTHER TREATMENT HAS BEEN ADMINISTERED TO ADDRESS THE INCOMPLETE NECK COVERAGE, AND NONE IS PLANNED AT THIS TIME. NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT,ANGIO, ETC.) ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143566 ↗
• MalfunctionApr 28, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.3MM DISTAL AND 4.4MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE WAS POSITIONED AND WHEN THE DOCTOR TRIED TO DEPLOY IT, THE DISTAL END WOULD NOT OPEN. IT WAS RECAPTURED TWICE, BUT IT STILL WOULD NOT OPEN. A SECOND DEVICE WAS TRIED, BUT THAT ALSO WOULD NOT OPEN. A THIRD DEVICE WAS USED WHICH FINALLY OPENED. THE DOCTOR THOUGHT THAT THE VESSEL TORTUOSITY CONTRIBUTED TO THE DEVICES NOT OPENING. THE MIDDLE PART HAD BEEN PLACED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THE DEVICES FAILED TO OPEN. THE PIPELINES WERE EACH RESHEATHED TWO OR LESS TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICES. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GOOD. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739727 ↗
• MalfunctionApr 28, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE DEVICES FAILED TO OPEN DISTALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC SEGMENT. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.3MM DISTAL AND 4.4MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE WAS POSITIONED AND WHEN THE DOCTOR TRIED TO DEPLOY IT, THE DISTAL END WOULD NOT OPEN. IT WAS RECAPTURED TWICE, BUT IT STILL WOULD NOT OPEN. A SECOND DEVICE WAS TRIED, BUT THAT ALSO WOULD NOT OPEN. A THIRD DEVICE WAS USED WHICH FINALLY OPENED. THE DOCTOR THOUGHT THAT THE VESSEL TORTUOSITY CONTRIBUTED TO THE DEVICES NOT OPENING. THE MIDDLE PART HAD BEEN PLACED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN THE DEVICES FAILED TO OPEN. THE PIPELINES WERE EACH RESHEATHED TWO OR LESS TIMES. NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICES. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE SAID TO BE GOOD. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739713 ↗
• MalfunctionMar 10, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE ICA. THE MAX AND NECK DIAMETERS WERE SAID TO BE SMALL. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 4.1MM DISTAL AND 4.1MM PROXIMAL. IT WAS REPORTED THAT THE PIPELINE WAS DEPLOYED AND THE DISTAL END DID NOT APPEAR TO OPEN. THE DOCTOR TRIED RECAPTURING AND DEPLOYING THE DEVICE, BUT IT STILL DID NOT OPEN. THE DOCTOR COMMENTED THAT THEY THOUGHT THE PETALS WERE STUCK ON THE DEVICE. THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND, AND LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE DOCTOR RESHEATHED THE PIPELINE 2 OR LESS TIMES, AND NO OTHER ACTIONS WERE TAKEN TO OPEN THE DEVICE. THE PIPELINE AND MICROCATHETER WERE REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN IMPERATIVE CARE TRACSTAR SHEATH, STRYKER AXS CATALYST 5 GUIDE CATHETER, AND A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456725 ↗
• MalfunctionJun 26, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTING CLARIFICATION THAT THE FIRST PIPELINE USED FAILED TO OPEN. THE SECOND PIPELINE WAS STUCK IN THE CATHETER AND WAS NOT DELIVERED AT ALL.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 10198324 ↗
• MalfunctionJun 15, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN AT THE DISTAL SEGMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 7MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE DEVICE WAS NOT IN A BEND, LESS THAN 50% WAS DEPLOYED, RE-SHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS WERE GOOD. ANCILLARY DEVICES INCLUDE A NEURON MAXX, XT 27 MICROCATHETER, TRAXXS GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10156227 ↗
• MalfunctionAug 19, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE HAD NOT BEEN POSITIONED IN A BEND. THE DEVICE HAD BEEN RESHEATHED LESS THAN TWO TIMES. THE DEVICE WAS NOT IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN RIGHT OPHTHALMIC SEGMENT, MEASURING 4MMX3MM, LANDING ZONE DISTAL 3.75MM PROXIMAL 4.4MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8908873 ↗
• MalfunctionNov 28, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE DEVICES FAILED TO OPEN AT THE DISTAL TIP. THE PATIENT WAS BEING TREATED FOR 2 ANEURYSMS. LEFT INTERNAL CAROTID ARTERY (ICA) TERMINUS ANEURYSM (PREVIOUSLY CLIPPED) AND SUPRACLINOID ANEURYSM PROXIMAL TO THE OPHTHALMIC. THE DISTAL ANEURYSM WAS SUCCESSFULLY TREATED WITH A PIPELINE. HOWEVER, WHILE ATTEMPTING TO TREAT THE LOWER ANEURYSM, THE PIPELINE FAILED TO BE RELEASED FROM THE PTS SLEEVES. THIS EVENT WAS REPORTED TO HAVE OCCURRED WITH 2 PIPELINE DEVICES. A NEW PIPELINE (B)(4) WAS USED TO TREAT THE PATIENT. THE ANATOMY THROUGH THE INTERNAL CAROTID ARTERY WAS VERY TORTUOUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8110917 ↗

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-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-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-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-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