PIPELINE PED-450-18 (UDI 00847536016446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536016446), received between Jul 26, 2019 and Apr 5, 2023 — classified as 12 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 16, 2026.

Recalls naming this device

1. Jul 13, 2021Open, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Activation 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 ANEURYSM WITH A MAX DIAMETER OF 29 MM AND A 7-10 MM NECK DIAMETER. THE LANDING ZONE SIZE IS UNKNOWN. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. IT IS UNKNOWN IF DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. IT WAS REPORTED THAT PIPELINE WAS PUT IN POSITION AND FAILED TO OPEN UPON DELIVERY. PRODUCT REMOVED AND NEW PIPELINE OPENED AND WORKED FINE. IT WAS REPORTED THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. IT IS UNKNOWN IF THE PIPELINE WAS POSITIONED IN A BEND. IT IS UNKNOWN HOW MUCH OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. IT IS UNKNOWN HOW MANY TIMES THE PIPELINE WAS RESHEATHED. IT IS UNKNOWN IF THERE WERE 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 PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE PATIENT HAD ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681600 ↗
• MalfunctionMar 8, 2022Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DID NOT DEPLOY/OPEN PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698464 ↗
• MalfunctionJul 9, 2021Unintended Movement; Activation Failure; Unintended Movement; 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 12143620 ↗
• MalfunctionMay 26, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHEN ATTEMPTING TO IMPLANT THE PIPELINE, THE DISTAL END OF THE STENT WOULD NOT OPEN. THE BODY AND P ROXIMAL PORTION UP TO THE RE-SHEATHING PAD WERE OPENED AND WELL APPOSED. AFTER RE-SHEATHING AND CHANGING THE DEPLOYMENT LOCATION, THE SAME RESULT WAS SEEN. ANOTHER RE-SHEATHING ATTEMPT WAS DONE, AND THE DEVICE WAS DEPLOYED WITH THE SYSTEM MORE LOADED. AGAIN, JUST THE DISTAL FEW MILLIMETERS WOULD NOT OPEN. IT WAS NOTED THE STENT WAS NOT POSITIONED IN A BEND, AND RE-SHEATHING WAS PERFORMED MORE THAN TWICE. THE DEVICE WAS REMOVED, AND A REPLACEMENT 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. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED A SUCCESSFUL PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 7 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885399 ↗
• MalfunctionFeb 4, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE MARKSMAN MICROCATHETER WAS USED TO DELIVER THE PIPELINE STENT, BUT THE STENT BECAME STUCK IN THE MICROCATHETER AND COULD NOT BE PUSHED OUT OF THE DISTAL END. IT WAS STATED THE PATIENT'S VESSELS WERE RELATIVELY TORTUOUS, AND THE STENT OF THE LARGE DIAMETER WAS DIFFICULT TO BE DELIVERED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. A REPLACEMENT STENT AND CATHETER WERE USED AS A RESULT. 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 STENT ATTACHED TO THE WALL WELL, AND THE DIVERSION EFFECTS WAS OBVIOUS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283483 ↗
• MalfunctionNov 24, 2020Unintended Movement; Activation Failure; Physical Resistance/Sticking; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DISTAL SEGMENT OF THE PIPELINE HAD FAILED TO OPEN. THE STENT WAS NOT PLACED IN A BEND, MULTIPLE PIPELINES WERE NOT BEING USED, AND AFTER REPEATED PUSHING IN THE BLOOD VESSEL, IT STILL COULD NOT BE OPENED. IT WAS NOTED THE TIP OF THE DEVICE JUMPED AND THE CATHETER MOVED DURING DEPLOYMENT, BUT WAS STATED IT NEEDED TO MOVE FOR NORMAL DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897098 ↗
• MalfunctionJun 26, 2020Activation Failure; Activation Failure

  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 10198317 ↗
• MalfunctionApr 20, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX DEVICE THAT FAILED TO DEPLOY AT THE DISTAL END AFTER THERE WAS RESISTANCE IN A MARKSMAN CATHETER. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT SUPRACLINOID ICA. THE ANEURYSM MAX DIAMETER WAS 15.82MM WITH A NECK DIAMETER OF 10.05MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THERE WAS SOME RESISTANCE OF THE PIPELINE IN THE MICROCATHETER. THE PIPELINE WAS SLOWLY DEPLOYED BUT FAILED TO OPEN AT THE DISTAL END. THE PIPELINE WAS REMOVED FROM THE PATIENT AND WAS REPLACED SUCCESSFULLY WITH A COMPETITOR'S PRODUCT. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9977534 ↗
• MalfunctionMar 13, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULDN'T OPEN MIDWAY THROUGH DEPLOYMENT. AS A RESULT IT WAS REMOVED AND THE MICROCATH ETER/PIPELINE WERE REPLACED AND THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WERE NO RELATED PATIENT SYMPTOMS. THE PATIENT WAS UNDERGOING TREATMENT OF A RIGHT ICA TO OPTHALMIC CAVERNOUS, UNRUPTURED, SACCULAR ANEURYSM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, POST PROCEDURE ANGIOGRAPHIC RESULTS WERE ACCEPTABLE. THE PATIENT'S VESSEL TORTUOSITY WAS UNKNOWN. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE ISSUE OCCURRED WITH LESS THAN 2 RESHEATHING ATTEMPTS MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9830809 ↗
• MalfunctionFeb 4, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL TIP LEAD WIRE DETACHED DURING RECAPTURE. THE DETACHED WIRE WAS RECAPTURED WITH THE PHENOM PLUS AND WAS SUCCESSFULLY REMOVED. RESISTANCE WAS FELT ON RETRIEVAL. THE PATIENT INJURY OCCURRED. THE POST ANGIOGRAPHIC RESULTS WERE GOOD. THE DEVICES WERE PREPARED AND USE PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT UNDERWENT TREATMENT OF A LEFT INTERNAL CAROTID ARTERY (ICA), UNRUPTURED, SACCULAR ANEURYSM. THE DISTAL LANDING ZONE WAS 3.7 MM AND THE PROXIMAL WAS 4.1 MM. THE VESSEL ANATOMY WAS SEVERE IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9665018 ↗
• MalfunctionOct 22, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FLEX FAILED TO OPEN AND WOULD NOT RESHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ICA ANEURYSM WITH A LANDING ZONE OF 4.5MM DISTAL AND 3.5MM PROXIMAL. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS TRYING TO RESHEATH AS THE PIPELINE WAS NOT OPENING DISTALLY, BUT IT WOULD NOT. THE PIPELINE WAS PULLED OUT OF THE BODY AND WOULD NOT RESHEATH ON THE TABLE EITHER. IT WAS NOTED THE DEVICE HAD RESISTANCE IN THE DISTAL PORTION OF THE CATHETER. THE ANGIOGRAPHIC RESULT SHOWED EVERYTHING WAS FINE AFTER DEPLOYING A SECOND PIPELINE WITH A NEW MICROCATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN NAVIEN 058 GUIDE CATHETER AND PHENOM 27 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9222137 ↗
• MalfunctionJul 26, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX PUSHWIRE BROKE, WHEN ATTEMPTING TO RECAPTURE AND REDEPLOY THE DEVICE. THE DEVICE WAS SUCCESSFULLY REMOVED AS THE BREAK OCCURRED WITH THE CATHETER. A SECOND DEVICE WAS USED TO TREAT. NO PATIENT INJURY OCCURRED. THE DEVICE WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED ANEURYSM. THE MAX DIAMETER WAS 10MM AND THE NECK WAS 4MM. THE DISTAL LANDING ZONE WAS 4MM AND THE PROXIMAL WAS 4.5MM. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830774 ↗

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-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-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