PIPELINE PED-475-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536016590), received between Sep 3, 2019 and Oct 19, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2020Activation Failure; Activation Failure

  IT WAS REPORTED THAT A PED-425-12 AND A PED-450-10 WERE IMPLANTED INTO THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) WITH NO ISSUES. A THIRD PIPELINE WAS THEN SELECTED (PED-475-10), PREPARED PER THE INSTRUCTIONS FOR USE (IFU), AND DELIVERED TO THE ANEURYSM SITE. IT WAS NOTICED THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN UPON UNSHEATHING FROM THE PHENOM 27 CATHETER. THE PIPELINE WAS NOT POSITIONED IN A BEND, LESS THAN 50% WAS OPENED, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE PIPELINE. THE DOCTOR REMOVED THE PIPELINE FROM THE PATIENT. THERE WAS NO INJURY TO THE PATIENT, AND POST-PROCEDURE ANGIOGRAPHY SHOWED THE ANEURYSM NECK WAS COVERED WITH THE TWO IMPLANTED PIPELINES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, THROMBOSED ANEURYSM OF THE RIGHT CAVERNOUS SEGMENT OF THE ICA WITH A MAX DIAMETER OF 6 MM AND A 3 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 WITHIN ACCEPTABLE LEVELS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10698183 ↗
• 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, OPTHALMIC 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 SUCCESSFULLY PLACING THE FIRST PIPELINE, THE PHYSICIAN WENT TO PUT A SECOND ONE IN. HOWEVER, THE DISTAL SECTION OF THE SECOND PIPELINE WOULD NOT OPEN. IT WAS NOTED THE MIDDLE AND DISTAL PORTIONS OF THE PIPELINE WERE POSITIONED IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, IT WAS RESHEATHED LESS THAN OR EQUAL TO TWO TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO TRY AND OPEN THE PIPELINE. THE DEVICE WAS REMOVED FROM THE PATIENT. 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 9683592 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT THE PATIENT WAS REPORTED TO HAVE BEEN TREATED FOR A POST TRAUMATIC AUTOMOBILE ACCIDENT THAT RESULTED IN A LEFT, PROXIMAL, INTERNAL CAROTID ARTERY (ICA) PSEUDOANEURYSM /FISTULA. THE PATIENT WAS INITIALLY TREATED WITH 2 FLOW DIVERTER. HOWEVER, SINCE THE BLOOD FLOW WAS STILL PRESENT THE PATIENT UNDERWENT A SECOND PIPELINE PROCEDURE ON (B)(6) 2019 AND A 3RD PIPELINE WAS IMPLANTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9580332 ↗
• MalfunctionSep 3, 2019Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL SEGMENT DURING A PROCEDURE. SECOND PIPELINE FLEX DEVICE TIP BROKE OF THE PUSHWIRE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT CAVERNOUS SEGMENT. MEASURING 8MMX5MM, LANDING ZONE DISTAL 4.5MM PROXIMAL 3.5MM. THE VESSEL WAS MODERATELY TORTUOUS. IT WAS REPORTED THAT THE GUIDECATHETER WAS PLACED THROUGH THE MAX SHEATH AND PLACED INTO THE PETROUS SEGMENT FOR SUPPORT. THE MEDTRONIC MICROCATHETER WAS PLACED INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND THE FIRST DEVICE WAS ADVANCED THROUGH THE CATHETER. THE PIPELINE FLEX DEVICE ADVANCED NORMALLY BUT THE DEVICE FAILED TO OPEN DISTALLY. THE DEVICE WAS RE-SHEATHED SEVERAL TIMES IN AN EFFORT TO GET THE DEVICE TO OPEN. AFTER SEVERAL ATTEMPTS THE DEVICE WAS REMOVED AND A NEW DEVICE WAS INSERTED. THE SECOND PIPELINE DEVICE (SAME LOT NUMBER) WAS ADVANCED THROUGH THE SAME CATHETER TO THE TIP OF THE CATHETER. THE PIPELINE DEVICE WAS DEPLOYED PER IFU AND AS THE DEVICE WAS BEING DRAGGED BACK INTO POSITION, THE DISTAL END OF THE PIPELINE FELL INTO THE ANEURYSM. THE PIPELINE WAS CONSTRAINED TO ALLOW THE DEVICE TO BE ADV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955979 ↗
• MalfunctionSep 3, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL SEGMENT DURING A PROCEDURE. SECOND PIPELINE FLEX DEVICE TIP BROKE OF THE PUSHWIRE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT CAVERNOUS SEGMENT. MEASURING 8MMX5MM, LANDING ZONE DISTAL 4.5MM PROXIMAL 3.5MM. THE VESSEL WAS MODERATELY TORTUOUS. IT WAS REPORTED THAT THE GUIDECATHETER WAS PLACED THROUGH THE MAX SHEATH AND PLACED INTO THE PETROUS SEGMENT FOR SUPPORT. THE MEDTRONIC MICROCATHETER WAS PLACED INTO THE MIDDLE CEREBRAL ARTERY (MCA) AND THE FIRST DEVICE WAS ADVANCED THROUGH THE CATHETER. THE PIPELINE FLEX DEVICE ADVANCED NORMALLY BUT THE DEVICE FAILED TO OPEN DISTALLY. THE DEVICE WAS RE-SHEATHED SEVERAL TIMES IN AN EFFORT TO GET THE DEVICE TO OPEN. AFTER SEVERAL ATTEMPTS THE DEVICE WAS REMOVED AND A NEW DEVICE WAS INSERTED. THE SECOND PIPELINE DEVICE (SAME LOT NUMBER) WAS ADVANCED THROUGH THE SAME CATHETER TO THE TIP OF THE CATHETER. THE PIPELINE DEVICE WAS DEPLOYED PER IFU AND AS THE DEVICE WAS BEING DRAGGED BACK INTO POSITION, THE DISTAL END OF THE PIPELINE FELL INTO THE ANEURYSM. THE PIPELINE WAS CONSTRAINED TO ALLOW THE DEVICE TO BE ADV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955959 ↗

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-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-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