PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-400-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000284367), received between Nov 17, 2023 and Feb 5, 2026 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 reports).

12 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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT PUSHWIRE WAS DAMAGED; THE TIP COIL BROKE AND DETACHED. THE BROKEN SEGMENT OF THE PUSHWIRE WAS REMOVED FROM THE PATIENT WITH THE MARKSMAN MICROCATHETER. THE PIPELINE WAS REMOVED FROM THE PATIENT. THE PRODUCT WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM WITH A MAX DIAMETER OF 7 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3.6 MM DISTALLY AND 4.1 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). MODERATE FRICTION OR DIFFICULTY WAS ENCOUNTERED DURING RETRIEVAL. THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271673 ↗
• MalfunctionDec 29, 2025Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS DAMAGE TO THE PIPELINE PUSHWIRE OR MARKSMAN CATHETER OBSERVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. NO ADDITIONAL STEPS OR DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909335 ↗
• MalfunctionDec 1, 2025Material Twisted/Bent; Activation Failure; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT DISTAL (TIP) END WAS SUCCESSFULLY OPENED AND ANCHORED, AND STENT DEPLOYMENT WAS CONTINUED, HOWEVER, THE MIDDLE SEGMENT OF THE STENT BECAME TWISTED AND COULD NOT BE OPENED DESPITE REPEATED ADJUSTMENTS. THE STENT AND PHENOM 27 MICROCATHETER WERE WITHDRAWN AND REPLACED WITH A MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, POSTERIOR COMMUNICATING ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.1 MM DISTALLY AND 4.2 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD STASIS WITHIN THE ANEURYSM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). ANC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681217 ↗
• MalfunctionOct 15, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE PHYSICIAN STATED DEPLOYMENT WAS SMOOTH WITH NO DIFFICULTY. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293864 ↗
• InjuryOct 15, 2025Unintended Ejection; Material Separation; Material Deformation; Unintended Movement; Physical Resistance/Sticking; Unintended Ejection; Material Separation; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT RESISTANCE WAS ENCOUNTERED WHEN DELIVERING THE PIPELINE INTO THE MICROCATHETER. SUB SEQUENT COMMUNICATION WITH THE SURGEON REVEALED THAT THE SECOND STENT ALSO ENCOUNTERED RESISTANCE. THE SURGEON HAD TO ROTATE THE PUSHWIRE TO PUSH IT INTO THE MICROCATHETER. RESISTANCE WAS ENCOUNTERED AT THE HUB OF THE MICROCATHETER. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE SURGEON BELIEVED THAT SINCE THE SAME ISSUE OCCURRED WITH THE SECOND STENT, IT WAS POSSIBLE THAT THERE WAS A PROBLEM WITH THE MICROCATHETER, WHICH CAUSED RESISTANCE DURING STENT DELIVERY. THIS RESISTANCE MAY HAVE DAMAGED THE STENT DURING THE DELIVERY PROCESS, RESULTING IN STENT DETACHMENT. THE STENT WAS NOT PREMATURELY OPENED. FOR THE DAMAGED STENT PED2-400-20, THE PUSHWIRE WAS NEITHER ROTATED NOR RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280883 ↗
• MalfunctionAug 27, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LARGE ANEURYSM IN THE LEFT C4 WITH A MAX DIAMETER OF 10 MM AND A 5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.72 MM DISTALLY AND 4.07 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL BLOOD FLOW IN THE PARENT ARTERY AND DISTAL VESSELS. IT WAS REPORTED THAT A LARGE ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY C4 SEGMENT WAS TREATED WITH A DENSE MESH PIPELINE STENT IM PLANTATION. A PIPELINE DENSE MESH STENT WAS SELECTED FOR IMPLANTATION. THE PHENOM27 STENT CATHETER WAS PASSED THROUGH THE GUIDEWIRE TO THE M1 SEGMENT, THE GUIDEWIRE WAS WITHDRAWN, THE DELIVERY SHEATH WAS PRESSED AGAINST THE PHENOM27 HUB PORT, AND THE STENT WAS DELIVERED TO THE M1 SEGMENT. AFTER THE STENT CATHETER CAME OUT, THE TIP END WAS OPENED. THE STENT TIP END WAS OPENED ABOUT 5MM, BUT IT COULD NOT BE FULLY OPENED. WHEN THE STENT WAS DEPLOYED TO 7-8MM, IT WAS FOUND THAT THE STENT STILL COULD NOT BE OPENED. THE PHYSICIAN LOCKED THE Y VALVE, PUSHED AND PULLED IT SEVERAL TIMES, BUT IT STILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907631 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD A PIPELINE FLEX WITH SHIELD IMPLANTED TO TREAT A LEFT INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT SACCULAR ANEURYSM VIA RIGHT RADIAL ACCESS. THE ANEURYSM MAX DIAMETER WAS 19MM AND THE ANEURYSM NECK WAS 6MM. AFTER THE PIPELINE WAS IMPLANTED, RAYMOND AND ROY ANEURYSM OCCLUSION CLASS 3 WAS NOTED WITH SIGNIFICANT STASIS IN THE ANEURYSM OBSERVED. THERE WAS NOT REPORTED DEVICE MALFUNCTION OR DEFICIENCY. POST-OPERATIVELY, NEUROLOGICAL DETERIORATION WAS NOTED; THE PATIENT EXPERIENCED NEW HEMIANOPSIA/QUADRANTANOPSIA ON THE RIGHT WITH RIGHT DRIFT. MAGNETIC RESONANCE IMAGING (MRI) SHOWED SCATTERED ACUTE INFARCTS. THE PATIENT'S DEXAMETHASONE WAS REDUCED TO 2 EVERY 12 HOURS. NO ADDITIONAL TREATMENT/INTERVENTION WAS REPORTED. HOWEVER, THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. THE PATIENT WAS NOTED TO BE RECOVERING. SITE ASSESSMENT CONCLUDED THE EVENTS WERE PROBABLY PROCEDURE RELATED AND POSSIBLY RELATED TO THE PIPELINE AND/OR DUAL ANTIPLATELET TREATMENT (DAPT). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS SUCCESSFULLY IMPLANTED. WALL APPOSI

  Patient problems: Headache; Stroke/CVA; Visual Impairment

  MAUDE report 22879853 ↗
• MalfunctionJul 29, 2025Unintended Ejection; Retraction Problem; Material Twisted/Bent; Activation Failure; Physical Resistance/Sticking; Premature Separation; Unintended Ejection; Retraction Problem; Material Twisted/Bent; Activation Failure; Physical Resistance/Sticking; Premature Separation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT C6 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.7 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.5MM DISTALLY AND 3.9MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 4.8MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS 0.  IT WAS REPORTED THAT THE PIPELINE PED2-400-25 DENSE MESH STENT WAS DELIVERED TO THE TARGET POSITION VIA THE PHENOM27 MICROCATHETER, AND STENT DEPLOYMENT BEGAN. AFTER THE DEPLOYMENT OF THE TIP END OF THE STENT, IT DID NOT FULLY OPENED. MULTIPLE PUSH-AND-PULL MANEUVERS WERE ATTEMPTED BUT FAILED TO RESOLVE THE ISSUE, AND THE MIDSECTION OF THE STENT WAS FOUND TO BE TWISTED. FURTHER ATTEMPTS TO PUSH AND PULL DID NOT FULLY RESOLVE THE ISSUE, AND IT WAS DECIDED TO RETRIEVE THE STENT. DURING THE PROCESS OF RETRIEVING THE TWISTED STENT INTO THE PHENOM27 MICROCATHETER, SIGNIFICANT RESISTANCE WAS FELT. AFTER COMPLETE RETRIEVAL, IT WAS FOUND THAT THE STENT WAS RETRACTED INTO THE PHENOM27 MICROCATHETER WITH LARGE RESISTANCE. UPON REMOVAL, THE STENT BECAME DETACHED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645642 ↗
• InjuryJun 18, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED PER REVIEW OF SOURCE DOCUMENTS, SUBJECT ALSO ENDORSED BLACK SPIRAL FLOATERS IN THE RIGHT EYE AND DULL LEFT SIDED HEADACHE. PIPELINES THAT REQUIRED A GUIDEWIRE WAS B327980, B333447.

  Patient problems: Headache; Muscle Weakness/Atrophy; Visual Disturbances

  MAUDE report 22286280 ↗
• InjuryApr 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECOVERING/RESOLVING. CORE-LAB HAD REPORTED OPHTHALMIC BRANCH STENOSIS IS ANGIOGRAPHICALLY OCCLUDED. THE SUBJECT HAS HAD A STROKE AND DEVICE THROMBOSIS AS REPORTED ADVERSE EVENTS (AES).

  Patient problems: Confusion/ Disorientation; Conjunctival Hemorrhage; Dizziness; Fatigue; Headache; Ischemia Stroke; Muscle Weakness/Atrophy; Obstruction/Occlusion

  MAUDE report 21833727 ↗
• MalfunctionSep 27, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 4.53 MM AND A 3.72 MM NECK DIAMETER. LANDING ZONE: DISTAL: 3.67 MM AND PROXIMAL: 3.98 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 0. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT UNDER THE GUIDANCE OF THE NERVE GUIDE WIRE, THE PHENOM27 STENT CATHETER WENT UPPER TO THE MIDDLE CEREBRAL ARTERY M2. THE PED2 DENSE MESH STENT WAS FULLY HYDRATED AND SMOOTHLY WENT UPPER TO THE STRAIGHT SECTION OF M1 THROUGH THE PHENOM27 STENT CATHETER. THE STENT WAS STABILIZED AND THE PHENOM27 MICROCATHETER WAS WITHDRAWN, DEPLOYED THE STENT TIP. AFTER THE STENT TIP WAS DEPLOYED, IT DID NOT OPEN SMOOTHLY. CONTINUING TO DEPLOY A SUFFICIENT LENGTH STILL COULD NOT SOLVE THE PROBLEM. TRIED TO GO UPPER THE NAVIEN CATHETER, PUSHED THE STENT FORWARD, AND WITHDREW THE WHOLE TO THE INTERNAL CAROTID ARTERY, BUT STILL COULD NOT SOLVE THE PROBLEM, SO IT WAS WITHD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323024 ↗
• MalfunctionJan 18, 2024Retraction Problem; Material Separation; Retraction Problem; Material Separation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WAS PLACED IN THE PATIENT'S BODY AND WAS NOT REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539908 ↗
• MalfunctionNov 17, 2023Activation Failure; Premature Separation; Activation Failure; Premature Separation

  ADDITIONAL INFORMATION RECEIVED THAT IT WAS CLARIFIED THAT THE "STENT WAS OFF-LOADED" MEANT THAT THE STENT WAS SEPARATED FROM THE PUSHING GUIDEWIRE BEFORE IT WAS RELEASED, SO THE STENT DID NOT RESPOND AT ALL WHEN PUSHING. IT WAS NOT THAT THE STENT COULDN'T BE OPENED, BUT IT WAS DETACHED IN ADVANCE BEFORE IT WAS DEPLOYED. THEREFORE, IN THE MIDDLE SECTION, THE SURGEON DISCOVERED THAT THERE WAS DISLODGEMENT AND DECIDED TO PULL THE ENTIRE STENT OUT OF THE BODY FOR THE SAFETY OF THE PATIENT TO DETERMINE THE SPECIFIC SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165890 ↗

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-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• 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-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-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