PIPELINE PED-425-20 (UDI 00847536016200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536016200), received between Apr 18, 2017 and Mar 29, 2022 — classified as 1 death, 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WAS COMPLETELY STUCK AND THE RESISTANCE WAS LARGE INSIDE THE CATHETER. NO MATTER IF THE TENSION WAS INCREASED OR DECREASED, IT COULD NOT BE DEPLOYED FORWARD OR RETRACTED. THE PIPELINE AND MARKSMAN CATHETER WERE WITHDRAWN FROM THE BODY AS A WHOLE AND IT WAS FOUND THAT THE MARKSMAN WAS PARTIALLY DEFORMED AND THE PIPELINE WAS COMPLETELY STUCK IN THE MIDDLE OF THE MARKSMAN. THE CATHETER WAS DAMAGED AT THE DISTAL END, THE DAMAGE WAS DESCRIBED AS ACCORDION. THE PUSHWIRE WAS NOT DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED ACCORDING TO THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. A DAPT (DUAL ANTIPLATELET) TREATMENT WAS ADMINISTERED AND THE PRU LEVEL WAS DOUBLE ANTIBODY FOR 7 DAYS. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. ANCILLARY DEVICES INCLUDE: A COOK 6F, A 5F 115 NAVIEN, A MARKSMAN CATHETER, AND A SYNCHRO14 GUIDEWIRE. 2021-12-24 E1 (FOR, REP, HCP): NO ADDITIONAL INFORMATION RECEIVED. 2022-JAN-28 ARED (FOR, REP):

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13944194 ↗
• MalfunctionOct 18, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE WAS PLACED IN A STRAIGHT BLOOD VESSEL, THE PIPELINE STILL COULD NOT BE OPENED. RE-SHEATHED 3 TIMES, THE PIPELINE STILL COULD NOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647691 ↗
• MalfunctionApr 14, 2021Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668021 ↗
• MalfunctionMar 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE MARKSMAN CATHETER WAS RUPTURED BY THE PIPELINE STENT WHEN THE PIPELINE WAS ADVANCED. IT WAS NOTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. BOTH DEVICES WERE REMOVED AND REPLACED TO CONTINUE THE PROCEDURE WHICH WAS CHANGED TO STENT ASSISTED COIL EMBOLIZATION AND COMPLETED SUCCESSFULLY. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS MODERATE. THERE WAS NO HARM OR INJURY TO THE PATIENT RELATED TO THE EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED COMPLETE EMBOLIZATION WITH SMOOTH ARTERY FLOW. ADDITIONAL INFORMATION RECEIVED NOTED THAT THERE WAS NO DAMAGE SEEN TO THE PIPELINE. REPORTED AS A RESULT OF ANALYSIS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555898 ↗
• MalfunctionMar 22, 2021Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICES WERE DELIVERED TO THE TARGET LOCATION SMOOTHLY. THE MARKSMAN MICROCATHETER WAS RETRACTED TO RELEASE THE PIPELINE STENT. THE PHYSICIAN WAITED FOR 5 SECONDS, THE STENT OPENED SMOOTHLY, AND THEY PULLED BACK THE RIVET. WHEN THE STENT REACHED THE T BIFURCATION IN THE NECK, THE TIP SUDDENLY SLIPPED TO THE PROXIMAL END OF THE TUMOR NECK. THE SURGEON TRIED TO ADJUST THE STENT AND DELIVER IT FORWARD, BUT THERE WAS RESISTANCE TOO GREAT IN THE DISTAL SEGMENT OF THE MICROCATHETER, AND THE STENT COULD NOT BE PUSHED. THE MARKSMAN AND PIPELINE WERE WITHDRAWN TOGETHER. IT WAS NOTED A CONTINUOUS FLUSH HAD BEEN USED, THERE WAS NO DAMAGE TO THE PUSHWIRE, AND THE CATHETER WAS BENT AND FLATTENED IN THE DISTAL SECTION. 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 ANGIOGRAPHIC RESULTS SHOWED AN ANEURYSM COULD NOT BE SEEN ON THE RADIOGRAPHY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, SMALL ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547794 ↗
• DeathSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO DEPLOYING 3 PIPELINE DEVICES, 2 OTHER PIPELINE WERE ATTEMPTED TO BE DEPLOYED BUT ENCOUNTERED A LOT OF RESISTANCE AND HAD TO BE WITHDRAWN. THE DEVICES WERE REPLACED WITH LARGER SIZES. GIANT ANEURYSM WAS NOTED AS AN INCIDENTAL FINDING. THE PATIENT WAS TREATED SUCCESSFULLY WITH THE DEVICES, BUT EXPERIENCED A PERFORATOR STROKE 24 HOURS POST PROCEDURE, FOLLOWED BY A HEMORRHAGE AND DEATH. THE DEVICES WERE PREPARED PER THE IFU. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR LEFT MCA ANEURYSM WITH A MAX DIAMETER OF 15MM AND A NECK DIAMETER OF 8MM. ANCILLARY DEVICES INCLUDE A BENCHMARK GUIDE CATHETER, PHENOM 27 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 10530947 ↗
• MalfunctionJun 1, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PIPELINE (PLI10) TIP WAS DAMAGED AND BECAME STUCK/LOCKED-UP IN THE DISTAL SEGMENT OF THE MICROCATHETER (PLI30) DURING DEPLOYMENT. THE PHYSICIAN RELEASED THE SLACK IN THE SYSTEM, BUT THE ISSUE DID NOT RESOLVE, AND THE DISTAL SEGMENT OF THE MICROCATHETER WAS CRUSHED. IT WAS FURTHER NOTED THAT THE MARKER BAND ON THE CATHETER WAS DAMAGED, AND THE CATHETER TIP WAS NOT SHAPED. ANOTHER PIPELINE (PLI20) AND MARKSMAN CATHETER (PLI40) WERE USED, BUT THERE WAS SEVERE RESISTANCE DURING DELIVERY. THE PUSHWIRE WAS BROKEN, AND THE MARKSMAN WAS FOUND TO BE ACCORDION AT THE DISTAL END. 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 FUSIFORM, UNRUPTURED ANEURYSM OF THE INTERNAL CAROTID OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 8.95MM AND A 9.34MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10107500 ↗
• MalfunctionOct 21, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT FIRST PIPELINE HAD DIFFICULTY DURING DELIVERED THROUGH MARKSMAN CATHETER AND DISTAL PART DID NOT OPEN. THE PATIENT WAS TREATED WITH REGULAR EMBOLISM. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT WITH FLOW DIVERSION FOR A SMALL UNRUPTURED AMORPHOUS RIGHT OPHTHALMIC ANEURYSM, MEASURING 3.07MM X 4.24MM, LANDING ZONE DISTAL 3.95MM PROXIMAL 4.13MM IT WAS REPORTED THAT THERE WAS SEVERE FRICTION DURING DELIVERED PIPELINE THROUGH THE MARKSMAN. IT WAS DIFFICULT TO FIND PIPELINE IN THE CAVERNOUS SINUS. AFTER THE SURGEON CONTINUED TO DELIVER, THE HEAD COULD NOT BE OPENED, AND THE RELEASE WAS CONTINUED. THE MIDDLE BRACKET WAS NOT ATTACHED TO THE WALL, AND THE SCAFFOLD WAS RECOVERED. IT WAS FOUND THAT IT COULD NOT BE RECYCLED. THEREFORE, THE WHOLE BODY WAS WITHDRAWN. AFTER THE WITHDRAWAL, THE MARKSMAN MICROCATHETER WAS BENT. THE SMALL WINGS OF THE PIPELINE TIP WERE NOT NORMALLY OPENED AND COULD NOT BE USED NORMALLY. THE PIPELINE WAS NOT POSITIONED IN A BEND. LESS THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. LESS THAN OR EQUAL TO 2 TIMES THE PIPELINE WAS RESHEATHED. THERE WERE NOT ANY ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9215705 ↗
• MalfunctionApr 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE DURING THE TREATING OF A LEFT OPHTHALMIC ANEURYSM, THE PIPELINE DEVICE DID NOT OPEN WHEN IT WAS DEPLOYED IN THE SIPHON. THE DEVICE WAS REMOVED, AND A NEW PIPELINE WAS USED TO TREAT THE PATIENT. THE SECOND DEVICE WAS REPORTED TO HAVE OPENED BETTER BUT WAS STILL NOT FULLY OPPOSED TO THE VESSEL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8481335 ↗
• MalfunctionOct 17, 2017Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX DEVICE FAILED TO OPEN AT IT MID SEGMENT DURING DELIVERY. THIS PATIENT HAD A SACCULAR ANEURYSM AT LEFT ICA PERI-OPHTHALMIC SEGMENT. THE ANEURYSM HAD MAXIMUM DIAMETER OF 6MM WITH NECK DIAMETER OF 4MM. THE LANDING ZONE DISTAL AND PROXIMAL ARTERY SIZES WERE 3.7MM AND 4.19MM RESPECTIVELY. THE PATIENT'S VESSEL TORTUOSITY WAS DESCRIBE AS SEVERE. IT WAS REPORTED THE DEVICE WAS PREPARED ACCORDING TO THE IFU. DURING THE FLOW DIVERSION TREATMENT, THE PHYSICIAN ATTEMPTED TO PLACE THE PIPELINE FLEX DEVICE IN A BEND OF THE VESSEL WITH THE MIDDLE SECTION OF THE DEVICE AT THE BEND. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES. THE FIRST 1/3 OF THE PIPELINE OPENED WITHOUT ANY DIFFICULT. WHEN ATTEMPTING TO DELIVER THE PIPELINES ACROSS AND PROXIMAL TO THE NECK OF THE ANEURYSM, THE PIPELINE WAS DIFFICULT TO OPEN. THIS PIPELINE DEVICE WAS REMOVED FROM THE PATIENT AND REPLACED WITH NEW DEVICE. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6956639 ↗
• MalfunctionApr 18, 2017Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THE THAT THE FLOW DIVERTER FAILED TO OPEN. THE DEVICE WAS ATTEMPTED TO BE DEPLOYED, HOWEVER, THE DISTAL END WAS NOT FULLY OPENING. RESHEATHING WAS ATTEMPTED ONCE. MORE THAN 50% OF THE DEVICE FAILED TO OPEN. THE DEVICE WAS REMOVED AND A NEW ONE WAS PLACED WITH OUT DIFFICULTY. THE TREATING LOCATION WAS THE VERTEBRAL ARTERY. NO PATIENT INJURY OCCURRED. THE ANATOMY WAS REPORTED TO HAVE BEEN MODERATE IN TORTUOSITY. PRU LEVEL WAS 260 AND IS BEING MONITORED. THE ANEURYSM WAS RUPTURED, PSEUDOANEURYSM, WITH 10MM MAX AND 7MM NECK. THE LANDING ZONE WAS 3.4MM X 4.2MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6502477 ↗

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-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-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