PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-375-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000284251), received between Nov 17, 2022 and May 13, 2025 — classified as 2 deaths, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PHENOM 27 MICROCATHETER THAT HAD RESISTANCE AND RESHEATHING A PIPELINE FLOW DIVERSION STENT AND BECAME DAMAGED. THE PATIENT WAS UNDERGOING A PROCEDURE VIA RIGHT FEMORAL ACCESS FOR FLOW DIVERSION TREATMENT OF A BRAIN ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER FLUSHED PER THE INSTRUCTIONS FOR USE (IFU). DURING DEPLOYMENT, THE PIPELINE NEEDED TO BE REPOSITIONED. HOWEVER, THERE WAS SIGNIFICANT RESISTANCE WHEN TRYING TO RESHEATH THE PIPELINE IN THE PHENOM MICROCATHETER AND THE CATHETER BECAME DAMAGED/KINKED AT THE DISTAL END AND STRETCHED IN THE MIDDLE. IT FELT ROUGH AND CURVED. IT WAS NOTED THAT FORCE WAS NOT APPLIED. THE CATHETER TIP WAS NOT STUCK OR ENTRAPPED AND WAS NOT STUCK IN THE GUIDE CATHETER. THERE WAS NO PATIENT VESSEL VASOSPASM. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010813 ↗
• InjuryApr 14, 2025Collapse; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration; Collapse; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Migration

  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; Paresis; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 21833758 ↗
• InjuryApr 1, 2025Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PIPELINE SHIELD WAS NOT REPORTED AS BEING RESHEATHED AFTER DEPLOYMENT. ON RE-REVIEW, THE EVENT COULD HAVE LED TO A POTENTIAL SADE. INCOMPLETE OPENING OF THE PIPELINE SHIELD DEVICE COULD HAVE POTENTIALLY LED TO AN ISCHEMIC STROKE IF INTERVENTION WAS PERFORMED TO OBTAIN COMPLETE WALL APPOSITION.

  Patient problems: Ischemia Stroke; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21746693 ↗
• InjuryDec 6, 2024Collapse; Activation, Positioning or Separation Problem; Unintended Movement; Migration; Collapse; Activation, Positioning or Separation Problem; Unintended Movement; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED A MIGRATION. BALLOON ANGIOPLASTY WAS COMPLETED. THERE WAS SOME PROXIMAL MIGRATION OF THE PIPELINE DEVICE AFTER PTA. A SECOND PIPELINE DEVICE WAS PLACED DISTAL TO THE EXISTING DEVICE WHICH RESULTED IN FULL ANEURYSM COVERAGE. POST IMPLANT COMPLETE STASIS AND NECK COVERAGE WAS NOTED AT THE END OF THE PROCEDURE. POST IMPLANT ANEURYSM OCCLUSION (RAYMOND AND ROY) AT THE END OF THE PROCEDURE WAS CLASS 3. THE PATIENT WAS ADMITTED TO ICU WHILE HOSPITALIZED FOR RETREATMENT STUDY PROCEDURE: ON (B)(6)2024 AND WAS DISCHARGED ON (B)(6)2024. RIST WAS NOT USED. ACCESS VESSEL WAS THE FEMORAL RIGHT. THE STUDY DEVICE WAS SUCCESSFULLY IMPLANTED IN THE SUBJECT. WALL APPOSITION WAS ACHIEVED. SIDE BRANCHES WERE COVERED BY THE PIPELINE DEVICE (OPTHALAMIC). NO DEVICE FLATTENING OR TWISTING WAS NOTED. ANCILLARY DEVICES: GUIDE CATHETER CATH ARMADILLO SELECTFLEX 27CM, MICROCATHETER CATH NEUR SELECT BER 5FR 130CM, GUIDE CATHETER 7FR 072 ARMADILLO, MICROCATHETER MEDTRONIC PHENOM 027.

  Patient problems: Muscle Weakness/Atrophy; Paresis; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 20872203 ↗
• InjuryNov 22, 2024Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED ACUTE NON-INTRACTABLE HEADACHE. THIS ADVERSE EVENT (AE) DID NOT RESULT IN ANY TREATMENT, HOSPITALIZATION, BLOOD TRANSFUSION, PERCUTANEOUS INTERVENTION, OR SURGICAL PROCEDURE. THE OUTCOME STATUS IS RECOVERED/R RESOLVED ON (B)(6)2024. THIS AE OCCURRED POST-PROCEDURE AND WAS POSSIBLY RELATED TO THE DISEASE UNDER STUDY. AE DID NOT RESULT IN A NEW OR WORSENING OF EXISTING NEUROLOGICAL DEFICIT. AE DID NOT RESULT FROM DEVICE DEFICIENCY. THE PATIENT PRESENTED TO THE EMERGENCY D DEPARTMENT (ED) WITH COMPLAINTS OF HEADACHE, DIZZINESS, AND GENERALIZED WEAKNESS STARTING AROUND 0300 ON (B)(6) 2024. UPON PRESENTATION TO THE ED PATIENT WAS ASYMPTOMATIC. COMPUTERIZED TOMOGRAPHY (CT) HEAD CLEAR. THE SITE ASSESSED THIS EVENT AS NOT CAUSING CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND NOT LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION, PROCEDURE, OR DEVICE. THE SPONSOR ASSESSED AS PENDING SOURCE DOCUMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, SIDEWALL LEFT INTERNAL CAROTID ARTERY (ICA) C6 ANEURYSM WITH A MAX DIAMETER OF 4.7MM AND A 3.6

  Patient problems: Dizziness; Headache; Muscle Weakness/Atrophy; Thrombosis/Thrombus

  MAUDE report 20762193 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE PIPELINE MIGRATION WAS NOT DETERMINED.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 18867210 ↗
• MalfunctionJan 25, 2024Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON WHY THE STENT CANNOT BE OPENED MAY BE DUE TO THE THINNESS OF THE DEPLOYING BLOOD VESSELS AND THE POOR OVERALL CONDITION OF THE PATIENT'S BLOOD VESSELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580246 ↗
• DeathNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED CEREBRAL VASOSPASM POST PROCEDURE. THE ADVERSE EVENT WAS TREATED WITH PERCU TANEOUS INTERVENTION. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED TO MONITOR THE PATIENT WHICH DEMONSTRATED MILD TO MODERATE VASOSPASM IN BASILAR ARTERY AND LEFT POSTERIOR CEREBRAL ARTERY (PCA). VESSELS WERE TREATED WITH INTRA-ARTERIAL (IA) VERAPAMIL. DSA ON NOV-08 DEMONSTRATED SOME PERSISTENT ANEURYSM SLOW FILLING, PED CONSTRUCT WIDELY PATENT. ON NOV-09, THE PATIENT HAD A SUDDEN NEUROLOGICAL DECLINE WITH SEIZURE ACTIVITY AND THEN WAS UNRESPONSIVE. THE PATIENT WAS HYPERTENSIVE AND BRADYCARDIC. INTRACRANIAL PRESSURE (ICP) FROM THE EXTERNAL VENTRICULAR DRAIN (EVD) WAS ELEVATED. THE PATIENT WAS MANUALLY VENTILATED AND THEN EMERGENTLY INTUBATED. CT HEAD SCAN AFTER THE EVENT SHOWED A SMALL AMOUNT OF NEW BLOOD IN THE RIGHT CP ANGLE AND 4TH VENTRICLE. A SECOND EVD WAS PLACED. 1 UNIT OF PLATELETS WERE TRANSFUSED. AFTER THE ANEURYSM RE-RUPTURE ON NOV-09, THERE WAS WORSENING HYDROCEPHALUS AND INCREASED ICP THAT BECAME REFRACTORY TO THERAPEUTIC MANEUVERS (MEDICAL AND SURGICAL-SECOND EVD PLACEMENT, MEDICAL THERAPY WITH HYPERTONIC SALINE, MANNITOL). PATIEN

  Patient problems: Bradycardia; Cognitive Changes; Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Hydrocephalus; Loss of consciousness; Obstruction/Occlusion; Rupture; Stenosis; Swelling/ Edema; Syncope/Fainting; Unspecified Nervous System Problem; Vasoconstriction

  MAUDE report 15815744 ↗
• DeathNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED CEREBRAL VASOSPASM POST PROCEDURE. THE ADVERSE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED TO MONITOR THE PATIENT WHICH DEMONSTRATED MILD TO MODERATE VASOSPASM IN BASILAR ARTERY AND LEFT POSTERIOR CEREBRAL ARTERY (PCA). VESSELS WERE TREATED WITH INTRA-ARTERIAL (IA) VERAPAMIL. DSA ON NOV-08 DEMONSTRATED SOME PERSISTENT ANEURYSM SLOW FILLING, PED CONSTRUCT WIDELY PATENT. ON NOV-09, THE PATIENT HAD A SUDDEN NEUROLOGICAL DECLINE WITH SEIZURE ACTIVITY AND THEN WAS UNRESPONSIVE. THE PATIENT WAS HYPERTENSIVE AND BRADYCARDIC. INTRACRANIAL PRESSURE (ICP) FROM THE EXTERNAL VENTRICULAR DRAIN (EVD) WAS ELEVATED. THE PATIENT WAS MANUALLY VENTILATED AND THEN EMERGENTLY INTUBATED. CT HEAD SCAN AFTER THE EVENT SHOWED A SMALL AMOUNT OF NEW BLOOD IN THE RIGHT CP ANGLE AND 4TH VENTRICLE. A SECOND EVD WAS PLACED. 1 UNIT OF PLATELETS WERE TRANSFUSED. AFTER THE ANEURYSM RE-RUPTURE ON NOV-09, THERE WAS WORSENING HYDROCEPHALUS AND INCREASED ICP THAT BECAME REFRACTORY TO THERAPEUTIC MANEUVERS (MEDICAL AND SURGICAL-SECOND EVD PLACEMENT, MEDICAL THERAPY WITH HYPERTONIC SALINE, MANNITOL). PATIENT

  Patient problems: Bradycardia; Cognitive Changes; Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Hydrocephalus; Loss of consciousness; Obstruction/Occlusion; Rupture; Stenosis; Swelling/ Edema; Syncope/Fainting; Unspecified Nervous System Problem; Vasoconstriction

  MAUDE report 15815663 ↗

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