PIPELINE PED-425-25 (UDI 00847536016231)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536016231), received between Mar 4, 2019 and Sep 21, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND, JUST TORTUOUS ANATOMY. THERE WAS NO FRICTION DURING DELIVERY OR POSITIONING, BUT THE DEVICE KEPT LINKING IN THE DISTAL TURN AND THE MORE PROXIMAL TURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506283 ↗
• MalfunctionMay 17, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS SUSPECTED THERE WAS INTERNAL DAMAGE TO THE CATHETER DUE TO BEING UNABLE TO DELIVER THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832740 ↗
• MalfunctionMay 14, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT FAILED TO OPEN IN THE MIDDLE DURING DEPLOYMENT, THEN HAD RESISTANCE IN THE MICROCATHETER DURING RETRIEVAL. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION AND COIL EMBOLIZATION OF AN UNRUPTURED SACCULAR ANEURYSM OF A RIGHT INTERNAL CAROTID ARTERY (ICA) CLINOID SEGMENT. THE ANEURYSM MAX DIAMETER WAS 25.3MM AND THE NECK DIAMETER WAS 7.8MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AFTER THE DISTAL TIP OF THE PIPELINE WAS DEPLOYED AND ANCHORED, THE MIDDLE SECTION OF THE PIPELINE COULD NOT BE OPENED. MORE THAN 50% OF THE PIPELINE WAS DEPLOYED AND THE STENT WAS NOT POSITIONED IN A VESSEL BEND. THE PHYSICIAN TRIED TO SWING THE PIPELINE TO OPENED IT AND THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES BUT THE PROBLEM COULD NOT BE RESOLVED. FINALLY, IT WAS DECIDED TO REPLACE THE STENT AND IT WAS RESHEATHED AND TRIED TO REMOVED WITH THE MICROCATHETER. HOWEVER, THE PIPELINE COULD NOT EXIT THE MICROCATHETER DURING RETRIEVAL SO BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825782 ↗
• MalfunctionOct 29, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHILE DEPLOYING THE PIPELINE STENT, THE MIDDLE OF THE DEVICE WOULD NOT OPEN. RESHEATHING WAS DONE TWICE, BUT THE ISSUE DID NOT RESOLVE. IT WAS NOTED THE STENT WAS POSITIONED IN A BEND, MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE STENT. THE CATHETER AND PIPELINE WERE REMOVED TOGETHER AND DISCARDED. REPLACEMENT DEVICES 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 OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 19 MM AND A 8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10757115 ↗
• MalfunctionJul 24, 2020Break; Retraction Problem; Break; Retraction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THERE WAS NO RESISTANCE FELT DURING DELIVERY OF THE PIPELINE. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE OR THE CATHETER AFTER REMOVAL. CONTINUOUS FLUSH WAS PROVIDED DURING THE PROCEDURE. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: Stenosis

  MAUDE report 10321150 ↗
• MalfunctionApr 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WAS NOT OPENING PROPERLY IN THE MIDDLE SECTION, EVEN AFTER MANY DIFFERENT METHODS AND MORE THAN 2 ATTEMPTS OF RESHEATHING, DUE TO A KINK. IT WAS NOTED THAT THE MIDDLE OF THE PIPELINE WAS POSITIONED IN A BEND, AND THAT 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. AS A RESULT THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER FROM THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM IN THE ICA WITH A MAX DIAMETER OF 15MM AND A NECK DIAMETER OF 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS CONFIRMED TO BE SEVERE. DUAL ANTIPLATELET TREATMENT WAS NOT ADMINISTERED. POST ANGIOGRAPHIC IMAGING SHOWED ANEURYSM FILLING POST PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481376 ↗
• MalfunctionMar 28, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX EMBOLIZATION DEVICE FELT RESISTANCE INSIDE THE MARKSMAN CATHETER AND DID NOT OPEN. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR AN INTRACRANIAL ANEURYSM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT AFTER THE MARKSMAN150 MICROCATHETER WAS PUT IN PLACE, THE DOCTOR WAS INTRODUCED INTO 4.25-25 PIPELINE FLEX. AFTER PED ENTERED THE MARKSMAN AND PUSHED A DISTANCE, IT WAS FOUND THAT THERE WAS VERY GREAT RESISTANCE, VERY DIFFICULT TO PUSH THE PED OUT OF THE MARKSMAN MICROCATHETER. AFTER THE RELEASE OF THE TIP END, IT WAS FOUND THAT THE PED STENT CANNOT CONTINUE TO PUSH OUT THE MICROCATHETER, THE RETRACEMENT OF THE MARKSMAN MICROCATHETER ALL RELEASED PED, FOUND THAT THE PED WAS NOT OPENED WELL, THE MULTI-STAGE WAS NOT ATTACHED TO THE VESSEL WALL. SURGERY WAS PERFORMED AFTER EXPANSION USING THE HYPERFORM BALLOON. THE PIPELINE WAS IMPLANTED WITHIN THE INTENDED LOCATION. THERE RESISTANCE WITHIN THE MARKSMAN CATHETER CAUSED DAMAGE TO THE CATHETER BODY AND PIPELINE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PRE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461741 ↗
• MalfunctionMar 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT WHILE DEPLOYING THE DEVICE, THE DISTAL END WOULD NOT OPEN. THE DEVICE WAS RESHEATHED 2 TIMES; HOWEVER, IT WOULD NOT OPEN. IT WAS NOTED THE PROXIMAL 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 MADE THE DECISION TO REMOVE THE DEVICE AND 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 LEFT ICA WITH A MAX DIAMETER OF 13MM AND A NECK DIAMETER OF 8MM. THE DISTAL AND PROXIMAL LANDING ZONES WERE 4MM AND 4.3MM. 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 8388518 ↗

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-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-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-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-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