PIPELINE PED-450-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536016354), received between Nov 28, 2018 and Apr 13, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2021Unintended Ejection; Unintended Ejection

  MEDTRONIC RECEIVED A REPORT THAT WHILE ATTEMPTING TO RECAPTURE THE DEVICE TO REPOSITION, THE PROXIMAL END CAME OFF THE RESHEATHING PAD. THE PHENOM 27 AND PIPELINE WERE REMOVED SUCCESSFULLY. A REPLACEMENT PRODUCT WAS USED 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4 MM AND A 3.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 60. ADDITIONAL INFORMATION RECEIVED INDICATED THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE, AND NO RESISTANCE WAS FELT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661745 ↗
• MalfunctionJan 12, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PUSHER WIRE. IT WAS NOT THAT THE STENT WAS PARTIALLY PROLAPSED FROM PULLING THROUGH THE PHENOM 27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155713 ↗
• MalfunctionJan 12, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PUSHER WIRE. IT WAS NOT THAT THE STENT WAS PARTIALLY PROLAPSED FROM PULLING THROUGH THE PHENOM 27.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155703 ↗
• MalfunctionSep 24, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN DEPLOYED THE DISTAL END OF THE PIPELINE, BUT IT DID NOT OPEN CORRECTLY. THE PIPELINE LOOKED LIKE A TULIP, AND WAS RECAPTURED TWICE BUT STILL DIDN'T LOOK RIGHT. IT WAS NOTED THEPIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% WAS OPENED, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. THE CATHETER AND PIPELINE WERE REMOVED TOGETHER, AND REPLACEMENT PRODUCTS WERE USED 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 GOOD RESULTS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 112.

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

  MAUDE report 10584383 ↗
• MalfunctionMar 2, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX FAILED TO OPEN. THIS EVENT OCCURRED DURING THE TREATMENT OF LEFT OPHTHALMIC ANEURYSM THAT WAS MEASURED 5 TO 6 MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. THE DISTAL LANDING ZONE WAS 3.28 MM, MIDDLE 3.84 MM AND PROXIMAL 4.68 MM. THE DEVICE DEPLOYED AND OPENED IN THE M1 AND DRAGGED BACK. HOWEVER, AS THE DEVICE WAS COMING AROUND THE OPHTHALMIC TURN, THE DEVICE FAILED TO OPEN. THE DEVICE WAS RESHEATHED 2 TIMES BUT STILL FAILED TO OPEN. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER PIPELINE. NO PATIENT INJURY OCCURRED. THE DEVICE WAS USED PER INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774899 ↗
• MalfunctionFeb 7, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT AFTER POSITIONING THE PIPELINE AND ATTEMPTING TO DEPLOY, THE DISTAL END OF THE DEVICE WOULD NOT OPEN. RESHEATHING WAS PERFORMED TWICE, BUT THE ISSUE DID NOT RESOLVE AND THE PHYSICIAN REMOVED THE PIPELINE AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITH NO ISSUE. IT WAS NOTED THE PROXIMAL AND DISTAL PORTION OF THE PIPELINE WAS POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, AND NO ADDITIONAL STEPS WERE TAKEN TO RESOLVE THE ISSUE. POST PROCEDURE ANGIOGRAPHIC RESULTS WERE VERY GOOD. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9683811 ↗
• 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 450-14 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 8110922 ↗

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-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-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-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-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-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