PIPELINE PED-425-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536016293), received between Jan 29, 2019 and Sep 28, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (5 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. How this data works · Data updated Oct 13, 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 · 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.

• InjurySep 28, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SECOND DEVICE WAS ALWAYS PLANNED GIVEN THE SIZE AND COMPLEXITY OF THE ANEURYSM.

  Patient problems: Aneurysm

  MAUDE report 17833218 ↗
• MalfunctionAug 19, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX THAT FAILED TO OPEN AT THE DISTAL END AND HAD RESISTANCE WITH THE MARKSMAN MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERTER TREATMENT OF AN UNRUPTURED FUSIFORM LEFT VERTEBRAL ARTERY V3 SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER AND NECK DIAMETER WAS 7.23MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE RESISTANCE WAS RELATIVELY LARGE AT THE BEGINNING OF THE PIPELINE DELIVERY BUT ADVANCEMENT WAS CONTINUED AND THE DEVICE WAS DELIVERED. DURING DEPLOYMENT, THE PIPELINE DISTAL TIP FAILED TO OPEN. REPEATED ATTEMPTS TO OPEN FAILED TWICE. LESS THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED 2 OR LESS TIMES; NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. IT WAS NOTED THAT THE RESISTANCE WAS ALSO SIGNIFICANT DURING THE RECOVERY OF THE PIPELINE BUT IT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. THE PIPELINE WAS REPLACED WITH A PED-450-35 WHICH WAS DELIVERED AND DEPLOYED SUCCESSFULLY WITH GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259691 ↗
• MalfunctionDec 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CATHETER WAS DELIVERED TO THE TARGET LOCATION. THE PED-425-35 WAS PLANNED TO BE USED, HOWEVER, IT COULD NOT BE PUSHED OUT OF THE CATHETER AFTER MANY ATTEMPTS. THE ENTIRE SYSTEM WAS WITHDRAWN, AND ANOTHER TREATMENT OPTION 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 ANEURYSM OCCLUSION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 15 MM AND A 10 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NOT AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER USED WAS A MARKSMAN. THERE WAS RESISTANCE IN THE DISTAL END OF THE CATHETER. THE TARGET ANEURYSM WAS LOCATED IN A VESSEL BEND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12972015 ↗
• MalfunctionSep 29, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN IN THE MIDDLE SECTION AND A PHENOM 27 MICROCATHETER THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A PROCEDURE TO FLOW DIVERTER TREATMENT OF AN UNRUPTURED SACCULAR RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 22.21MM AND THE NECK DIAMETER WAS 13.93MM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PIPELINE WAS DELIVERY BY THE PHENOM 27 MICROCATHETER TO THE INTENDED LOCATION. THE PIPELINE COULD NOT BE OPENED IN THE MIDDLE SECTION DURING THE PROCESS OF WITHDRAWING THE PHENOM TO RELEASE THE STENT. THE PHYSICIAN WAITED 10 MINUTES TO RECOVER AND RELEASE AGAIN BUT THE PIPELINE STILL COULD NOT BE OPENED. IT WAS NOTED THE PIPELINE WAS MORE THAN 50% DEPLOYED WHEN THE FAILURE TO OPEN OCCURRED. THERE WERE NO ADDITIONAL STEPS OR DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THE DEVICES WERE PREPARED AND THE CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). RESISTANCE WITH THE PHENOM 27 MICROCATHETER WAS OBSERVED AND IT COULD NOT BE USED TO COMPLETE THE PROCEDURE. THE PHENOM CATHETER WAS REPLACED AND THE PIPELINE WAS REPLACED WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546979 ↗
• MalfunctionSep 10, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE BECAME STUCK IN THE DISTAL END OF THE PHENOM CATHETER DURING DELIVERY. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE CAVERNOUS SINUS ARTERY. THE MAX DIAMETER WAS 4.67MM*4.32MM. THE NECK DIAMETER WAS 4.87MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.56MM DISTAL AND 4.13MM PROXIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 5MM IN DIAMETER. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PHYSICIAN RELEASED THE LOAD/SLACK IN THE SYSTEM, BUT THIS DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE DISTAL SECTION OF THE CATHETER WAS DAMAGED. THERE WAS NO DAMAGE TO THE PUSHWIRE. THE DEVICES WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE WERE NORMAL. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN 8F SHEATH, 5F125 MEDTRONIC GUIDE CATHETER, AND SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456323 ↗
• MalfunctionJul 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE WHICH BECAME STUCK AT THE DISTAL END OF THE MARKSMAN CATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED FUSIFORM ANEURYSM IN THE RIGHT CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 25.3MM AND THE NECK DIAMETER WAS 11.8MM. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND THE CATHETER FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING WITHDRAWAL OF THE PIPELINE, IT BECAME STUCK AT THE TOP OF THE MARKSMAN MICROCATHETER AND COULD NOT ADVANCE OR WITHDRAW. THE DEVICES WERE REMOVED TOGETHER AND BOTH WERE REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED SLOWED BLOOD FLOW WITH SOME CONTRAST AGENT REMAINING. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207661 ↗
• MalfunctionMar 18, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE PIPELINE WAS RESHEATHED TWICE DURING THE PROCEDURE, THE VESSEL TORTUOSITY WAS MODERATE, AND ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE FOLLOWING REMAINED UNKNOWN/UNREPORTED: WHICH SECTION OF THE PIPELINE FAILED TO OPEN, IF THE STENT WAS POSITIONED IN A BEND WHEN IT FAILED TO OPEN, IF THERE WAS ANY RESISTANCE FELT, IF THERE WAS ANY DEVICE DAMAGE, AND THE LESION CHARACTERISTICS BEING TREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515482 ↗
• MalfunctionJul 10, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE TIP OF TWO PIPELINES WERE NOT OPENING. PRIOR TO THE EVENT, THE MARKSMAN WAS POSITIONED INTO PLACE AND THE IT WAS ADJUSTED AND RIVETED AND WITHDRAWN TO DEPLOY THE PIPELINE AND THE REPORTED EVENT OCCURRED. THE PHYSICIAN REPEATEDLY ADJUSTED THE DEVICE; HOWEVER, THE TIP STILL WOULD NOT OPEN. THE PIPELINE WAS REPLACED BY ANOTHER PIPELINE AND NEW MARKSMAN AND THE SAME EVENT OCCURRED. CONSIDERING THE PATIENT¿S TORTUOUS VASCULATURE AND LONG DURATION OF THE PROCEDURE, THE OPERATION WAS COMPLETED. IT WAS NOT KNOWN HOW. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED AMORPHOUS ANEURYSM MEASURING 20MM X 12MM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 4.0MM X 4.2MM. THAT VASCULATURE WAS SEVERE IN TORTUOSITY. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE MARKSMAN WAS WITHDRAWN AND REPEATEDLY ADJUSTED BUT THE ISSUE PERSISTED. ANCILLARY DEVICES: MARKSMAN 150, COOK 7F LONG SHEATH GUIDE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777454 ↗
• MalfunctionFeb 12, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIS PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL END DURING A PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A MEDIUM SIZE LEFT UNRUPTURED AMORPHOUS ANEURYSM, MEASURING 15-53MMX8.07MM, LANDING ZONE DISTAL 3.51MM PROXIMAL 4.33MM. THE VESSEL WAS NORMALLY TORTUOUS. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS PUSHED FROM THE CATHETER AND DID NOT OPEN AT THE TIP. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO OPEN THE DEVICE WITHOUT SUCCESS. FINALLY, THE WHOLE SYSTEM WAS WITHDRAWN. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8333784 ↗
• InjuryJan 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT AT AFTER THE MARKSMAN MICROCATHETER WAS IN PLACE, THE PIPELINE FLEX WAS DELIVERED TO THE DISTAL END. WHEN IT WAS READY TO BE RELEASED OUTWARD, IT WAS FOUND THAT IT CANNOT BE PUSHED OUT. THE CATHETER WAS FLUSHED WITH HEPARIN. UPON ON ASSESSMENT, THE CATHETER AND THE PUSHWIRE WERE NOTED TO HAVE BEEN DAMAGED. AT THE END OF THE EMBOLIZATION PROCEDURE, A SMALL BLEED WAS IDENTIFIED. THE PATIENT WAS SYMPTOMATIC: MYDRIASIS (DILATION OF THE PUPIL OF THE EYE) IN ONE OF EYE. THE INTRACRANIAL HEMATOMA WAS CLEARED OUT AND THE PATIENT REGAINED CONSCIOUSNESS. THE HEMORRHAGE WAS IN A DISTAL MCA/ M2, WHICH WAS CAUSED BY NON-PIPELINE FLEX INSTRUMENTS. THE HEPARIN WAS NEUTRALIZED, AND THE OPERATION WAS COMPLETED. POSTOPERATIVE ANEURYSM STILL DEVELOPED, AND THE IMPLANTATION OF FLOW-GUIDED EMBOLIZATION DEVICE WAS CANCELLED. THE HEMORRHAGE MAY HAVE BEEN CAUSED BY THE GUIDEWIRE, OR MAYBE THE CASE TIME WAS TOO LONG. THE EXACT CAUSE OF THE HEMORRHAGE IS UNKNOWN. THE ANEURYSM WAS REPORTED TO BE IN THE INTERNAL CAROTID ARTERY CAVERNOUS SEGMENT. IT WAS SACCULAR, WITH A MAX DIAMETER OF 20.3MM AND A NECK OF 12MM. THE LANDING ZONE WAS 3.7MM DISTALLY AND 4.37MM PROXIMAL. THE ANATOMY

  Patient problems: Intracranial Hemorrhage

  MAUDE report 8285892 ↗

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-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-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-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