PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000284091), received between Dec 22, 2023 and Apr 8, 2025 — classified as 5 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON FOLLOW UP DSA IMAGING OBTAINED (B)(6) 2024, THE SUBJECT HAD 75-95% STENOSIS OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THIS WAS A BRANCH ARTERY THAT WAS COVERED BY THE STUDY DEVICE DURING THE INDEX PROCEDURE AND THEREFORE RELATED TO THE STUDY DEVICE.

  Patient problems: Bacterial Infection; Hemorrhagic Stroke; Ischemia Stroke; Respiratory Arrest; Respiratory Insufficiency; Stenosis

  MAUDE report 21798909 ↗
• DeathJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2024-DEC-18 LSH 1295031620 X3, LSH 1303461980 X2 (HCP, SDY): MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO PED2 PIPELINES HAD COMPLICATIONS. THE PATIENT HAD A WORSENING PULMONARY EDEMA ON (B)(6) 2024. TACHYPNEA BEGAN (B)(6) AND PATIENT WAS INTUBATED FOR AIRWAY PROTECTION. GIVEN IV LASIX. (B)(6) CXR CONCERNING FOR PULMONARY EDEMA. CXR REPEAT (B)(6) WITH IMPROVED PULMONARY EDEMA (B)(6): DESATURATES WHEN REPEATEDLY REPOSITIONED AND DURING PERIODS OF AGITATION, CHEST X-RAY REVIEWED, NOTABLE FOR WORSENING PULMONARY EDEMA. GIVEN LASIX. CONTINUE AGGRESSIVE PULMONARY HYGIENE. (B)(6) TOLERATING GENTLE DIURESIS FOR PULMONARY EDEMA. EXTENDED HOSPITALIZATION. POSSIBLY RELATED TO INDEX PROCEDURE. (B)(6): CXR WITH MULTIFOCAL CONSOLIDATION AND MEETING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) CRITERIA (B)(6): LASIX STARTED FOR PULMONARY EDEMA AND ARDS (B)(6): CT CHEST SHOWING MULTIFOCAL PNEUMONIA AND ARDS (B)(6): TCD MILD INCREASED VELOCITY IN LEFT ANTERIOR CEREBRAL ARTERY (ACA). PRECEDEX WEANED. (B)(6): TRANSFUSED 1U PRBC FOR LOW HGB. INCREASED FIO2 DUE TO DYSSYNCHRONOUS BREATHING ON VENT AND DESATURATING. (B)(6): REQUIRE HIGH FIO2 DUE TO DESATURATIONS. (B)(6): MAINTAINING FIO2

  Patient problems: Anemia; Bronchopneumonia; Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Respiratory Insufficiency; Stenosis; Swelling/ Edema; Thrombosis/Thrombus; Vasoconstriction; Ventilator Dependent

  MAUDE report 21107415 ↗
• DeathJan 8, 2025Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PIPELINE PATIENT EXPERIENCED ANEMIA. ACTION WAS TAKEN: DAILY CBC, TRANSFUSION FOR HGB 7, AND TS COMPLETED. ON 26-DEC. ONE UNIT OF RBC WAS TRANSFUSED. THE EVENT WAS CAUSALLY RELATED TO THE DISEASE UNDER STUDY. IT WAS NOTED THAT THE DEVICE WAS INSERTED INTO THE MICROCATHETER AND WAS RESHEATHED.

  Patient problems: Anemia; Bronchopneumonia; Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Respiratory Insufficiency; Stenosis; Swelling/ Edema; Thrombosis/Thrombus; Vasoconstriction; Ventilator Dependent

  MAUDE report 21107413 ↗
• DeathJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD TWO PIPELINES OF THE SAME MODEL/LOT IMPLANTED WHO HAD POST-OPERATIVE COMPLICATIONS. IT WAS REPORTED THAT THE TWO PIPELINE FLEX WITH SHIELD STENTS WERE IMPLANTED ON (B)(6) 2024. NO DEVICE MALFUNCTION OR INTRAOPERATIVE ISSUE WAS REPORTED. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AFTER EXPERIENCING FEVER AND PROGRESSIVE DECLINE IN MENTAL STATUS. IMAGING RESULTS WERE SUGGESTIVE OF CONCERN FOR CEREBRAL VASOSPASM ASSOCIATED WITH SUBARACHNOID HEMORRHAGE (SAH) IN EVOLUTION. THE PATIENT UNDERWENT A PROCEDURE FOR INTRAARTERIAL VASODILATOR (VERAPAMIL 20MG) INTERNAL CAROTID ARTERY (ICA) INFUSION WITH MILD IMPROVEMENT AND WAS MONITORED. IT WAS CONSIDERED LIKELY THAT VASOSPASM CAUSED THE SYMPTOMS OF FEVER AND SIMILAR SYMPTOMS TO PNEUMONIA AND SEPTIC SHOCK. THE PATIENT OUTCOME WAS NOTED AS "RECOVERING/RESOLVING." THE EVENT REQUIRED PATIENT HOSPITALIZATION AND INTERVENTION BUT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. SITE ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLE RELATED TO THE PATIENT DISEASE UNDER STUDY AND/OR THE INDEX PROCEDURE BUT NOT RELATED TO THE IMPLANTED PIPELINES OR ACCESSORY DEVICES.

  Patient problems: Cognitive Changes; Fever; Intracranial Hemorrhage; Vasoconstriction

  MAUDE report 21093492 ↗
• DeathJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD TWO PIPELINES OF THE SAME MODEL/LOT IMPLANTED WHO HAD POST-OPERATIVE COMPLICATIONS. IT WAS REPORTED THAT THE TWO PIPELINE FLEX WITH SHIELD STENTS WERE IMPLANTED ON (B)(6) 2024. NO DEVICE MALFUNCTION OR INTRAOPERATIVE ISSUE WAS REPORTED. ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED AFTER EXPERIENCING FEVER AND PROGRESSIVE DECLINE IN MENTAL STATUS. IMAGING RESULTS WERE SUGGESTIVE OF CONCERN FOR CEREBRAL VASOSPASM ASSOCIATED WITH SUBARACHNOID HEMORRHAGE (SAH) IN EVOLUTION. THE PATIENT UNDERWENT A PROCEDURE FOR INTRAARTERIAL VASODILATOR (VERAPAMIL 20MG) INTERNAL CAROTID ARTERY (ICA) INFUSION WITH MILD IMPROVEMENT AND WAS MONITORED. IT WAS CONSIDERED LIKELY THAT VASOSPASM CAUSED THE SYMPTOMS OF FEVER AND SIMILAR SYMPTOMS TO PNEUMONIA AND SEPTIC SHOCK. THE PATIENT OUTCOME WAS NOTED AS "RECOVERING/RESOLVING." THE EVENT REQUIRED PATIENT HOSPITALIZATION AND INTERVENTION BUT WAS NOT LIFE-THREATENING AND DID NOT RESULT IN PATIENT DISABILITY. SITE ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLE RELATED TO THE PATIENT DISEASE UNDER STUDY AND/OR THE INDEX PROCEDURE BUT NOT RELATED TO THE IMPLANTED PIPELINES OR ACCESSORY DEVICES.

  Patient problems: Cognitive Changes; Fever; Intracranial Hemorrhage; Vasoconstriction

  MAUDE report 21093474 ↗
• MalfunctionJul 8, 2024Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  THE PIPELINE HAD BEEN PLACED ON STRAIGHT SECTION. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19694592 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE SITE RESPONDED TO SAFETY QUERY AND STATED THAT INDEX PROCEDURE WAS ERROR AND THEY UPDATED THE R<(>&<)>R AT PROCEDURE TO CLASS 3 (RESIDUAL ANEURYSM). THEREFORE, NO WORSENING OF R<(>&<)>R FROM INDEX IS REPORTED. THERE WERE NO ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE ANEURYSM . THE DEVICE IS STILL IN USE. CORELAB REVIEW OF THE IMAGING FOR 18-DAY ALSO REPORTED "RESIDUAL ANEURYSM" AT THIS VISIT.

  Patient problems: Aneurysm

  MAUDE report 19125641 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S NAUSEA WAS RESOLVED ON (B)(6) 2023 AND THE PATIENT'S DIZZINESS WAS RESOLVED ON (B)(6) 2023. THE PATIENT'S MRS SCORE WAS 1 AT 3 MONTH FOLLOW UP. THE SPONSOR ASSESSED THE SYMPTOMS AS A CASUAL RELATIONSHIP TO THE STUDY DEVICE. THE SPONSOR AND CLINICAL SITE STATED THE PATIENT'S NAUSEA WAS A SYMPTOM OF THE CEREBELLAR STROKE.

  Patient problems: Diplopia/Double Vision; Dysphasia; Headache; Hydrocephalus; Ischemia; Ischemia Stroke; Nausea

  MAUDE report 18386006 ↗

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-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-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-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-2402-2021 · Jul 13, 2021 · Open, Classified
  Pipeline Flex Embolization Device
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• 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-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-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