PIPELINE PED-400-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536015876), received between Nov 19, 2018 and Dec 1, 2022 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2022Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED AFTER THE PIPELINE WAS OPENED, IT WAS IN THE STRAIGHT SEGMENT OF THE DISTAL M1. NO OTHER STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898155 ↗
• MalfunctionSep 30, 2020Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT IT APPEARED THE DISTAL END OF THE PIPELINE WAS STILL ATTACHED ON ONE SIDE AFTER PUSHING THE WIRE. RESISTANCE WAS FELT AND THE MICROCATHETER WAS NOT MOVING/PASSIVELY UNSHEATHING. A SINGLE SHOT VIEW WAS THEN PERFORMED WHICH SHOWED THAT THE DISTAL END WAS STRETCHING. THIS TENSION CAUSED THE PIPELINE TO SEPARATE FROM THE RESHEATHING PAD AS SEEN UNDER FLUOROSCOPY. THE PHYSICIAN THEM STOPPED PUSHING, TIGHTENED THE TOUHY ON THE DELIVERY WIRE, AND PUSHED THE TORQUEING DEVICE AGAINST THE TOUHY TO LOCK IT. THE WIRE TIP THEN CAME INTO THE MICROCATHETER AND "CORKED" THE PIPELINE INTO IT, SO THE SYSTEM WAS REMOVED. THERE WERE NO RELATED PATIENT SYMPTOMS. THE PATIENT WAS UNDERGOING TREATMENT OF A RIGHT ICA ANEURYSM OF THE SUPERIOR HYPOPHYSEAL.

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

  MAUDE report 10607283 ↗
• MalfunctionMar 5, 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 ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 6MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS AN OBVIOUS NARROWING IN THE PROXIMAL 1/3 SEGMENT OF THE PIPELINE DURING DEPLOYMENT. THE NARROWING WAS NOT RESOLVED, SO THE DEVICE WAS REMOVED AND A SECOND DEVICE WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. IT WAS NOTED THE MIDDLE SEGMENT OF THE PIPELINE WAS POSITIONED IN A BEND, MORE THAN 50% HAD BEEN DEPLOYED, RESHEATHING WAS PERFORMED MORE THAN TWO TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE DEVICE FULLY COVERED THE ANEURYSM NECK. THERE WAS PARTIAL FILLING OF THE ANEURYSM WITH CONTRAST IN A SEMI-HEMISPHERICAL FASHION. 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 9793534 ↗
• MalfunctionJan 24, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DEVICE STUCK IN THE PHENOM CATHETER. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR AN UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY (ICA) PARA OPHTHALMIC ANEURYSM WITH PIPELINE TREATMENT. LANDING ZONE DISTAL 3.20MM PROXIMAL 3.80MM. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT PRE IMAGES WERE TAKEN AND THE PIPELINE SIZE WAS CHOSEN. AS THE PIPELINE WAS BEING SEATED INTO THE ROTATING HEMOSTASIS VALVE (RHV) AND THE PIPELINE WAS ATTEMPTED TO ADVANCE, IMMEDIATELY THE STAFF FELT RESISTANCE. THE RHV WAS CHECKED AND NOTHING SEEMED TO BE AWRY. THEY TRIED TO PULL BACK AND THE PIPELINE WOULD NOT RETRACT. AT THIS POINT IN TIME, IT WAS FELT THE DEVICE WAS NOT SAFE TO CONTINUE TO PUT IN THE BODY, SO REQUESTED TO HAVE IT REMOVED FROM THE PATIENT ALONG WITH THE PHENOM THAT IT WAS STUCK IN. THE PIPELINE NEVER MADE IT OUT OF THE PHENOM CATHETER INTO THE PATIENT. IT NEVER CAUSED HARM DURING THE CASE, IT JUST DELAYED THE PROCEDURE. I DID NOTICE IT APPEARED SOMETHING WAS STUCK IN THE END OF THE PHENOM UPON REMOVAL FROM THE PATIENT, SO I HAVE INCLUDED BOTH THE PIPELINE AND THE CATHETER. THE PHYSICIAN FEELS THE RESISTANCE BEGAN AS TH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9629064 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT AFTER PLACEMENT OF THE PIPELINE DEVICE, THE PHYSICIAN OPTED TO WAIT 10 MINUTES TO ENSURE NO CLOT FORMATION ON THE DEVICE DUE TO HIGHER PRU LEVEL. DURING THIS PERIOD, ONE OF THE FLUSH BAGS RAN OUT AND AIR WAS INTRODUCED INTO THE CATHETER AND INTO THE ARTERIES. UPON ANGIOGRAPHY IT WAS NOTED THE LACK OF FILLING IN THE ANTERIOR CEREBRAL ARTERY (ACA) WHICH HE BELIEVED TO BE DUE TO AN AIR EMBOLISM. THE PATIENT WAS REPORTED TO HAVE POSSIBLE EXPERIENCED A RIGHT ACA STROKE DUE TO THE AIR EMBOLISM. THE PATIENT¿S PRU LEVEL WAS 253. THE PIPELINE WAS OPEN WITH STAGNATION IN THE ANEURYSM. PARTIAL ACA BLOCKAGE DUE TO AIR EMBOLISM. THIS EVENT OCCURRED DURING THE TREATMENT OF A RIGHT ICA OPHTHALMIC ANEURYSM THAT WAS UNRUPTURED. THE MORPHOLOGY WAS SACCULAR, THE MAX DIAMETER WAS 8MM AND THE NECK WAS 4MM. THE LANDING ZONE WAS 3.8MM DISTALLY AND THE PROXIMAL WAS 4.18MM. THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: Air Embolism

  MAUDE report 9219942 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  GOTO, S., IZUMI, T., NISHIHORI, M., ISHIDA, M., ISHIDA, T., OTAWA, M., . . . WAKABAYASHI, T. (2019). CARDIAC ARREST INDUCED BY CAROTID SINUS REFLEX ACTIVATION DURING FLOW-DIVERTER STENT DEPLOYMENT. WORLD NEUROSURGERY, 124, 22-24. DOI:10.1016/J.WNEU.2018.12.136 MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF CARDIAC ARREST DURING PIPELINE FLEX IMPLANTATION. THE PATIENT WAS UNDERGOING PIPELINE IMPLANTATION IN THE RETREATMENT OF MULTIPLE ANEURYSMS IN THE INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM HAD BEEN COILED 6 MONTHS PRIOR. IT WAS REPORTED THAT DURING THE PROCEDURE, THE MARKSMAN WAS TRIAXIALLY ADVANCED THROUGH A 5-FRENCH NAVIEN. THE NAVIEN WAS PLACED IN THE CAVERNOUS SEGMENT OF THE ICA, AND THE MARKSMAN WAS THEN NAVIGATED TO THE SECOND SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PATIENT¿S BLOOD PRESSURE AND HEART RATE AT THAT TIME WERE 110/70 MM HG AND 66 BPM, RESPECTIVELY. A PIPELINE FLEX WAS INSERTED AND DEPLOYED FROM THE PROXIMAL END OF THE ICA POSTERIOR COMMUNICATING ARTERY BIFURCATION. DURING THE DEPLOYMENT, CARDIAC ARREST OCCURRED WHEN THE NAVIEN AND MARKSMAN WERE PUSHED FARTHER TO PROMOTE ADEQUATE OPENING AND APPOSITION OF THE PED AGAINST THE VESSEL WALL AND INCREASE THE NECK

  Patient problems: Arrhythmia

  MAUDE report 8364185 ↗
• MalfunctionJan 29, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX (PED) WAS SELECTED AND DELIVERED INTO THE TREATING VESSEL AND INITIALLY OPENED. HOWEVER, WHEN THE DEVICE WAS DEPLOYED ON THE BEND, IT FAILED TO CONTINUE OPENING. THEREFORE, THE PED WAS REMOVED. A NEW CATHETER AND NEW PED WERE SUCCESSFULLY USED TO TREAT THE PATIENT. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS BEING TREATED FOR A RIGHT OPHTHALMIC ANEURYSM THAT WAS 5MM. THE ANATOMY WAS TORTUOUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8287422 ↗
• MalfunctionNov 19, 2018Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING TREATMENT OF ANEURYSM LOCATION IN THE INTERNAL CAROTID (IC) C3, SACCULAR SHAPE, UNRUPTURED, 8MM NECK WIDTH, LANDING ZONE VESSEL DIAMETER 3MM DISTAL 4MM PROXIMAL. THE SIZE OF ANEURYSM WAS 13 MM, PIPELINE FLEX DEVICE DID NOT OPEN DURING A PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH ONE MEDTRONIC FLOW DIVERTER; HOWEVER, IT DID NOT COVER THE NECK COMPLETELY. THE TREATING PHYSICIAN DECIDED TO PLACE AN ADDITIONAL FLOW DIVERTER. THE REPORTED PIPELINE WAS SELECTED, HOWEVER, THIS DEVICE FAILED TO DEPLOY (OPEN DISTALLY). THE DEVICE WAS RESHEATHED 4 TIMES OR MORE BUT STILL THE DISTAL END OF THE FLOW DIVERTER DID NOT OPEN. THE WALL APPOSITION BECAME POOR RESULTING FIXATION FAILURE OF THE FLOW DIVERTER. THE PROTECTIVE SLEEVE WAS OPENED, BUT THE PIPELINE WOULD STILL DID NOT DEPLOY. THE ANATOMY WAS SEVERE AND SMALL IN DIAMETER. THE PATIENT IS CURRENTLY BEING MONITORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8085447 ↗

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