PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-325-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000284060), received between Oct 24, 2022 and Jan 21, 2025 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CIGARETTE SMOKING, ANEMIA, ANXIETY, PREMATURE VENTRICULAR CONTRACTIONS, A TRANSIENT ISCHEMIC ATTACK, AND AN ANEURYSM OF THE CAVERNOUS PORTION OF THE LEFT INTERNAL CAROTID ARTERY (L-ICA) EXPERIENCED AN ADVERSE EVENT. THE ANEURYSM WAS LOCATED IN THE LEFT HEMISPHERE C4 SIDEWALL, WAS UNRUPTURED, AND HAD A SACCULAR MORPHOLOGY WITH A MAXIMUM DIAMETER OF 3.4 MILLIMETERS AND A NECK DIAMETER OF 3.0 MM. THE PIPELINE FLEX SHIELD DEVICE WAS IMPLANTED, WITH A DISTAL LANDING ZONE ARTERY SIZE OF 3.3 MILLIMETERS AND A PROXIMAL SIZE OF 3.4 MM. IT WAS NOTED THAT DURING A ONE-YEAR FOLLOW-UP, THE RAYMOND AND ROY CLASSIFICATION WAS REPORTED AS CLASS 3, WHEREAS IT WAS PREVIOUSLY REPORTED AS CLASS 1 AT A SIX-MONTH CTA IMAGING FOLLOW-UP. THE SITE WAS QUERIED TO CONFIRM THE CLASS 3 STATUS. THE DEVICE REMAINED IMPLANTED WITH COMPLETE WALL APPOSITION, AND NO DEVICE DEFICIENCIES OR ADVERSE EVENTS WERE REPORTED. THE PATIENT HAD NO SYMPTOMS, AND THE MODIFIED RANKIN SCORE (MRS) WAS 0 AT ONE YEAR. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFO

  Patient problems: Aneurysm

  MAUDE report 21200582 ↗
• MalfunctionNov 14, 2024Unintended Ejection; Detachment of Device or Device Component; Physical Resistance/Sticking; Unintended Ejection; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT TWO PED2 PIPELINS ENCOUNTERED ISSUES. WHEN TRYING TO RECAPTURE THE PIPELINE, THE PUSHER WIRE BECAME DISENGAGED FROM THE BRAID/STENT AND WE WERE UNABLE TO FULLY RECAPTURE IT. THERE WAS A PATIENT INVOLVED IN THIS EVENT. THERE WERE NO IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687137 ↗
• MalfunctionNov 14, 2024Unintended Ejection; Material Separation; Detachment of Device or Device Component; Physical Resistance/Sticking; Unintended Ejection; Material Separation; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED IT APPEARS THAT THERE WAS AN ISSUE WITH THE DEVICE ITSELF. WAS NOT ABLE TO IDENTIFY WHY IT HAPPENED. THERE WAS NO PATIENT OR PROCEDURE ISSUE OTHER THAN HAVING TO OPEN MULTIPLE DEVICES. IT HAPPENED WHEN WE WERE TRYING TO RECAPTURE IT. UNABLE TO OBSERVE ANY TYPE OF DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20687071 ↗
• MalfunctionSep 19, 2023Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE WOULD NOT UN-SHEATH AND WOULD NOT DEPLOY AT THE DISTAL END. THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS LESS THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. THE LANDING ZONE ARTERY SIZE MEASUREMENTS WERE 2.9MM DISTALLY AND 3.62MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.   ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777965 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT REGARDING A RE-RUPTURED ANEURYSM POST PIPELINE INSERTION. THE PATIENT WAS POST-OP FOR TREATMENT OF A BLISTER-LIKE, RUPTURED ANEURYSM IN THE RIGHT ICA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THERE WERE NO ISSUES THAT AROSE DURING INTERVENTION. THE CASE WENT VERY SMOOTH AND EVERYTHING LOOKED GOOD. THE ANGIOGRAPHIC RESULT POST PROCEDURE "LOOKED GOOD". THE PATIENT HAD A RE-RUPTURE OF AN ANEURYSM POST-PROCEDURE. IT WAS NOTED THE PATIENT HAD TWO ANEURYSMS AND ONE OF THE TWO WAS POSSIBLY A RUPTURED ANEURYSM. IT WAS ALSO NOTED THAT THE PATIENT HAD COVID-19. NO OTHER PRE-EXISTING CONDITIONS WERE KNOWN.  THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL AT THE TIME OF THE PROCEDURE.  THE PIPELINE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU) AT THE TIME OF THE PROCEDURE. ANCILLARY DEVICES INCLUDE A PHENOM PLUS 120CM AND A PHENOM 27 150CM.

  Patient problems: Rupture

  MAUDE report 15835319 ↗
• DeathOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH TWO PED2 PIPELINES HAD COMPLICATIONS AND DIED. WORSENED MASS EFFECT WITH 6 MM MIDLINE SHIFT ON RIGHT SIDE OF BRAIN. WORSENING OF HYDROCEPHALUS AND SUBARACHNOID HEMORRHAGE (SAH). EXTERNAL VENTRICULAR DRAIN PLACES (E.V.D) DUE TO ADVERSE EVENT (AE). WORSENING OF HYDROCEPHALUS AND SAH. ECTERNAL VENTRICULAR DRAIN PLACEMENT DUE TO AE. NEW FOCAL DISSECTION AND ASSOCIATE HIGH-GRADE STENOSIS INVOLVING TEH DISTAL CERVICAL RIGHT INTERNAL CAROTID ARTERY JUST BEFORE IT ENTERS TEH CAROTID CANAL. MODERATE VASOSPASM OF RIGHT ANTERIOR CIRCULATION AND MILD VASOSPASM OF LEFT ANTERIOR CIRCULATION AND LEFT POSTERIOR CEREBRAL ARTERY. THIS WAS TREATED WITH TRANSCATHETER INTRA-ARTERIAL INFUSION OF VERAPAMIL 20 MG TO RIGHT INTERNAL CAROTID ARTERY AND VERAPAMIL 10 MG TO THE LEFT INTERNAL CAROTID ARTERY (ICA). WORSENING OF LEFT-SIDED WEAKNESS PER PHYSICIAN. WORSENING OF LEFT-SIDED WEAKNESS PER NEUROLOGICAL CHECK BY PHYSICIAN. PATIENT WAS REINTUBATED DUE TO WORSENING OF RESPIRATORY DISTRESS. AS OF (B)(6) 2022 CT THORAX SCAN: RIGHT UPPER, RIGHT LOWER AND LEFT LOWER LOBE AIRSPACE DISEASE. CONSOLIDATION LIKELY REPRESENTING COMBINATION OF PNEUMONIA AND AT

  Patient problems: Cerebral Edema; Hydrocephalus; Intracranial Hemorrhage; Muscle Weakness/Atrophy; Respiratory Insufficiency; Stenosis; Stroke/CVA; Swelling/ Edema; Vascular Dissection; Vasoconstriction

  MAUDE report 15657718 ↗

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-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-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-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-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