PIPELINE PED-475-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536016743), received between Jan 4, 2019 and Aug 17, 2021 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2021Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE A PIPELINE FAILED TO OPEN IN THE DISTAL END AND THE MIDDLE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT CAVERNOUS SEGMENT OF THE ICA. THE MAX DIAMETER WAS 12MM, THE NECK DIAMETER WAS 8.6MM, AND THE DEPTH WAS 11MM. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.8MM DISTAL AND 4.8MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS WITHIN THE RANGE DEEMED APPROPRIATE BY THE DOCTOR. IT WAS REPORTED THAT THE PIPELINE OPENED IN A "FISH MOUTH" MANNER DISTAL, AND CONTINUED DEPLOYING WITH GOOD OPENING FOR 1-2MM. THE DEVICE WOULD THEN NOT OPEN DESPITE MULTIPLE RE-SHEATHS AND INCREASING AND DECREASING LOAD IN THE SYSTEM. IT WAS DECIDED TO REMOVE THE PIPELINE SINCE IT WAS ONLY OPEN FOR A FEW MMS DISTAL AND EVEN THAT SECTION DID NOT APPEAR RIGHT. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD BEEN RESHEATHED MORE THAN TWO TIMES. NO ADDITIONAL STEPS OR OTHER DEVICES WERE TAKEN TO OPEN THE PIPELINE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED ALL VESSELS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12334409 ↗
• MalfunctionJul 19, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU), AND THE PATIENT VESSEL TORTUOSITY WAS MODERATE. THE EVENT WAS CLARIFIED THAT THE PIPELINE FAILED TO OPEN AT THE DISTAL END OF THE STENT AND THE DEVICE HAD NOT BEEN PLACED IN A VESSEL BEND. RE-SHEATHING WAS ATTEMPTED TO RESOLVE THE ISSUE, BUT IT WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12194256 ↗
• MalfunctionJun 9, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DISTAL END OF THE DEVICE WAS DEPLOYED IN A STRAIGHT SEGMENT AND NOT IN A BEND/CURVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971014 ↗
• MalfunctionJan 4, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A MARKSMAN WHICH HAD ACCORDING TYPE DAMAGE AT THE DISTAL END RESULTING IN RESISTANCE DURING DELIVERY OF THE PIPELINE STENT DURING WHICH THE STENT FAILED TO OPEN AND BROKE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED SACCULAR LEFT CAVERNOUS SINUS ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 13.2MM AND THE NECK DIAMETER WAS 6.2MM. VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN MICROCATHETER WAS IN PLACE. THE PIPELINE WAS BEING DELIVERY. DURING THE PIPELINE DEPLOYMENT THE DISTAL END FAILED TO OPEN. THE PHYSICIAN ATTEMPTED TO RELEASE THE SLACK IN THE SYSTEM BUT IT DID NOT RESOLVE THE ISSUE. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE STENT WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. DURING THE DEPLOYMENT PROCESS, MARKSMAN MICROCATHETER BECAME ACCORDIONED AND THE PIPELINE BECAME STUCK AND THE STENT BROKE INTO TWO PIECES. IT WAS NOTED THAT THE DISTAL PIECE OF THE PIPELINE REMAINED WITHIN THE CATHETER. BOTH DEVICES WERE REMOVED TOGETHER AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109321 ↗
• MalfunctionDec 21, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS RESISTANCE FELT WITH ALL FOUR PIPELINE DEVICES. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE, AND NO OTHER TREATMENT WAS REQUIRED FOR THE PATIENT AT THE TIME OF THE REPORT. IT WAS NOTED THE PHYSICIAN MAY RESCHEDULE THE PATIENT WITH A DIFFERENT MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047609 ↗
• MalfunctionOct 19, 2020Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM 27 MICROCATHETER WAS DELIVERED, AND THE PIPELINE WAS DELIVERED TO THE ANEURYSM WITH NO I SSUES. AFTER TIP IMAGING, THE COIL WAS FULLY EXPOSED, AND THE WHOLE PART WAS RETRIEVED TO THE LANDING SITE FOR DEPLOYMENT. HOWEVER, DURING DEPLOYMENT, IT WAS FOUND THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. IT WAS NOTED THE STENT WAS NOT IN A BEND, LESS THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. IT WAS NOTED A NEUROFORM EZ STENT WAS ALSO USED IN THE PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT. 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 NO ABNORMALITIES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INVERTED TRIANGLE, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY OP HTHALMIC SEGMENT WITH A MAX DIAMETER OF 2.87 MM AND A 2.87 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10701359 ↗
• InjuryOct 13, 2020Migration; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER USED WAS A PHENOM 27, AND THERE WAS NO DAMAGE TO THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10672079 ↗
• MalfunctionApr 29, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION: A SMALLER SIZE PIPELINE DEVICE WAS USED TO TREAT THE PATIENT. THE COMPLAINT PIPELINES WERE IN THE MIDDLE CEREBRAL ARTERY M1 AND NOT IN A BEND. IT WAS DIFFICULT TO OPEN THE TIP OF THE PIPELINE STENTS, ATTEMPTED DEPLOYING IN A LONGER LENGTH, SWINGING, AND WITHDRAWING. THE CATHETER TIPS WERE NOT UNDER STRESS. IMAGES HAVE BEEN ATTACHED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10010566 ↗
• MalfunctionDec 27, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT IF PIPELINE FLEX INCOMPLETE OPENING DURING A PROCEDURE. THE PATIENT WAS UNDERGIONG TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM IN THE CAVERNOUS INTERNAL CAROTID ARTERY (ICA.) VESSEL TORTUOSITY WAS DESCRIBED AS SEVERE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED. DURING THE PROCEDURE, THE COOK SHUTTLE AND NEURO MICROCATHETER WAS ADVANCED TO THE DESIRED LOCATION, THEN THE MARKSMAN WAS NAVIGATED TO THE M1 MIDDLE CEREBRAL ARTERY (MCA). THE PIPELINE FLEX WAS ADVANCED SMOOTHLY UNTIL THE DISTAL MARKER COINCIDED WITH THE MARKSMAN DISTAL MARKER. THE PED WAS OPENED 5MM IN STRAIGHT SEGMENT. POST OPENING OF DISTAL END OF THE STENT, THE WHOLE DEVICE WAS PULLED TO THE LANDING ZONE FROM WHERE THE DEPLOYMENT NEED TO BE STARTED. THE DEVICE OPENED WELL AT THE DISTAL END BUT HAD DIFFICULTY OPENING IT IN MID SEGMENT. IT WAS REPORTED THAT MANEUVERING WAS ATTEMPTED, THE DEVICE WAS RESHEATHED TWICE AND RE-DEPLOYED; THE DEVICE WOULD NOT OPEN IN THE MID-SEGMENT. THE PED AND MARKSMAN WERE REMOVED. THE DEVICE WAS REPLACED WITH OTHER MANUFACTURER'S DEVICE TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9526710 ↗
• InjurySep 15, 2019Retraction Problem; Migration; Retraction Problem; Migration

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE UNEVENTFUL PLACEMENT OF THE PIPELINE FLEX, THE CATHETER WAS ADVANCED THROUGH THE PIPELINE TO RECAPTURE THE DELIVERY SYSTEM. HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE DELIVERY SYSTEM WAS UNABLE TO BE PULLED BACK INTO THE CATHETER. THE PUSHWIRE AND THE CATHETER WERE WITHDRAWN TOGETHER. HOWEVER, WHEN THE PTFE BLADE PASSED THROUGH THE PIPELINE FLEX, THE PTFE BLADE PULLED ON THE DEVICE, WHICH CAUSED THE DEVICE TO SHIFT AND NO LONGER COMPLETELY COVER THE ANEURYSM NECK. UPON ASSESSMENT OF THE REMOVED DEVICES, IT WAS FOUND THAT THE PTFE BLADE COULD NOT BE PULLED INTO THE MICROCATHETER, AND THE MICROCATHETER WAS NOTED TO HAVE ACCORDION AND STRETCHED DAMAGES IN THE DISTAL SECTION. AN ADDITIONAL DEVICE WAS PREPARED AND PLACED. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS HYDRATED AS PER THE IFU. THE PUSHWIRE WAS NOT ROTATED. THE ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9067306 ↗
• MalfunctionJan 7, 2019Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT PIPELINE DEVICE CAN NOT BE PUSHED OUT OF THE MARKSMAN CATHETER AT DISTAL SECTION. IT WAS ALSO REPORTED THAT PIPELINE WAS FAIL TO OPEN AT DISTAL SECTION. IT WAS REPORTED THAT PIPELINE WAS PUSHED OUT OF THE MICROCATHETER AND FOUND THAT THE TIP END WAS CURLED AND COULD NOT CONTINUE TO BE RELEASED. THE PIPELINE WAS REMOVED FROM THE PATIENT WITH A SNARE/RETRIEVAL DEVICE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A MEDIUM UNRUPTURED SACCULAR ANEURYSM LOCATED IN LEFT INTERNAL CAROTID ARTERY. MEASURING 12.46MM X 7.95MM, LANDING ZONE DISTAL 4.02MM PROXIMAL 4.36MM. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE ANGIOGRAPHIC RESULT WAS COMPLETELY EMBOLISM POST PROCEDURE. THE VESSEL WAS NORMAL TORTUOUS. NO PATIENT INJURY WAS REPORTED. THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. YES, THE CATHETER FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE CATHETER WAS NOT DAMAGED. THE PUSHWIRE WAS NOT DAMAGED. THE PIPELINE WAS NOT POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. LESS THAN 2 ATTEMPTS FOR RESHEATHING WERE ATTEMPTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8223285 ↗
• MalfunctionJan 4, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX FAILED TO OPEN IN THE DISTAL SECTION AFTER REPEATED ATTEMPTS AND WAS REMOVED FROM THE PATIENT. PRIOR TO THE EVENT, THE MARKSMAN MICROCATHETER WAS ADVANCED INTO PLACE AND THEN THE PIPELINE FLEX WAS ADVANCED THROUGH THE MICROCATHETER AND PUSHED INTO THE DISTAL OPEN AREA. AT THAT POINT, IT WAS REPORTED THE PHYSICIAN FOLLOWED THE STANDARD OPERATION TO OPEN THE FLOW DIVERTER, BUT IT COULD NOT BE OPENED. IT WAS DECIDED TO WITHDRAW BOTH THE MARKSMAN MICROCATHETER AND THE PIPELINE FLEX AND THEY WERE REPLACED WITH A NEW MARKSMAN AND PIPELINE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS TO THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. IT IS UNKNOWN WHAT THE CAUSE OF THE ISSUE WAS. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 10.2 MM X 4.5 MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. THE DISTAL AND PROXIMAL LANDING ZONE WAS 3.87 MM X 4.73 MM RESPECTIVELY. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY AND PRU LEVEL WAS NOT AVAILABLE. POST PROCEDURAL ANGIOGRAPHY SHOWED SLOW

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8218872 ↗

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-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-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