PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-475-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000284657), received between Nov 21, 2022 and Dec 22, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE SHIELD COULD NOT BE ANCHORED SECURELY. THE DENSE MESH STENT WAS OPENED IN THE MIDDLE C EREBRAL ARTERY, THEN RETRACTED TO THE TARGET POSITION, BUT IT SUDDENLY FELL DURING THE DEPLOYMENT PROCESS. THE DENSE MESH STENT WAS REPLACED, BUT IT STILL FELL INTO THE ANEURYSM. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR DENSE MESH STENT IMPLANTATION FOR ANEURYSM TREATMENT OF AN AMORPHOUS, UNRUPTURED BASILAR ARTERY ANEURYSM WITH A MAX DIAMETER OF 4.3 MM AND A 3 MM NECK DIAMETER. THE LANDING ZONE WAS 3.5 MM DISTALLY AND 4.7 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 4.9 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS MULTIPLE ANEURYSMS OF THE BASILAR ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872739 ↗
• MalfunctionDec 8, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 12.7MM AND A 6.3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.9MM DISTALLY AND 4.6MM PROXIMALLY. IT WAS REPORTED THAT UNDER GUIDEWIRE GUIDANCE, THE PHENOM 27 CATHETER FORMED A LOOP WITHIN THE ANEURYSM AND WAS THEN ADVANCED INTO THE DISTAL PARENT VESSEL, FOLLOWED BY THE INTERMEDIATE CATHETER. AFTER UNLOOPING, THE FIRST STENT (475-35) WAS SELECTED AND DEPLOYED SUCCESSFULLY. SLIGHT DISTAL SHORTENING WAS OBSERVED, RAISING CONCERNS ABOUT DISTAL ANCHORING. THEREFORE, IT WAS DECIDED TO PLACE AN ADDITIONAL DENSE MESH STENT AS A BRIDGE. UNDER GUIDEWIRE GUIDANCE, THE MICROCATHETER WAS ADVANCED THROUGH THE FIRST DENSE MESH STENT, AND THE DEPLOYMENT OF THE SECOND DENSE MESH STENT WAS INITIATED. HOWEVER, THE SECOND STENT COULD NOT BE OPENED AT THE DISTAL SECTION DESPITE VARIOUS MANEUVERS SUCH AS MANIPULATION AND REPOSITIONING. THE DENSE MESH STENT WAS THEN RETRIEVED AND REMOVED FROM THE BODY. AFTER REPLACING IT WITH A NEW STENT, THE PROCEDURE WAS COMPLETED SUCCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743434 ↗
• MalfunctionSep 18, 2025Unintended Ejection; Retraction Problem; Activation Failure; Physical Resistance/Sticking; Unintended Ejection; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE "DISLODGEMENT" WAS REFERRING TO DETACHMENT OF THE STENT BODY AND THE STENT PUSH ROD. THERE WAS NOT PREMATURE DEPLOYMENT. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THE CATHETER WAS FLUSHED PER IFU DURING THE PROCEDURE. THE PIPELINE HAD BEEN PLACED IN A RELATIVELY STRAIGHT PART OF THE VESSEL, NOT ABSOLUTELY BEND. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING. THE RESISTANCE DURING RETRIEVAL WAS IN THE DISTAL END OF THE MICROCATHETER. THE CAUSE OF THE RESISTANCE AND DISLODGEMENT WAS NOT DETERMINED. IT WAS NOTED THAT LARGE-SIZED PEDS OFTEN CANNOT BE OPENED IMMEDIATELY OR MAY NOT BE OPENED THROUGH MANIPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085421 ↗
• MalfunctionSep 4, 2025Material Frayed; Structural Problem; Material Deformation; Material Frayed; Structural Problem; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT ONE PIPELINE FLEX WITH SHIELD STENT WAS DELIVERED WITHOUT EVERTED SLEEVE, WAS MISSHAPED, HAD INCOMPLETE OPENING, AND HAD BURRS, AND ANOTHER ONE HAD POOR WALL APPOSITION. THE PATIENT WAS UNDERGOING DENSE MESH STENT FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS, INTERNAL CAROTID ARTERY ANEURYSM WITHA MAX DIAMETER OF 8 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERY DIAMETER WAS 4.3 MM DISTALLY AND 4.8 MM PROXIMALLY. VASCULAR ACCESS WAS GAINED VIA THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED NORMAL BLOOD VESSELS AND POOR STENT OPENING. IT WAS REPORTED THAT 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). THE FIRST STENT, PED2-475-30, WAS OPENED WITHOUT AN EVERTED SLEEVE. WHEN THE TIP WAS EXPOSED, IT APPEARED TRUMPET-SHAPED. THE SURGEON EVEN COMMENTED ON HOW EASY IT WAS TO OPEN, HOWEVER, AFTER A SHORT DEPLOYMENT, THE SHAPE WAS INCORRECT, SO THE STENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964476 ↗
• MalfunctionMay 9, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE FAILURE TO OPEN, RESISTANCE, AND DAMAGE WAS NOT DETERMINED. THE RESISTANCE OCCURRED AT THE DISTAL END OF THE CATHETER. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994279 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED PATIENT SYMPTOM OF DIPLOPIA WAS RESOLVED AND PATIENT RECOVERED AS OF 22-SEP-2025.

  Patient problems: Aneurysm; Diplopia/Double Vision; Thrombosis/Thrombus; Visual Impairment

  MAUDE report 21773968 ↗
• MalfunctionApr 9, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ADDITIONAL PIPELINE AND MARKSMAN THAT WERE RETURNED WERE RELATED TO ANOTHER COMPLAINT REPORT. BECAUSE THE EXTRACORPOREAL RECOVERY THE PIPELINE COULD NOT BE PUSHED OUT/PULLED BACK FROM THE MARKSMAN, SO THE MARKSMAN WAS CUT OFF TO WITHDRAW THE PIPELINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069650 ↗
• InjuryMar 26, 2024Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT A PIPELINE SHIELD HAD A DEPLOYMENT ISSUE. THE DEVICE WAS REMOVED AND A REPLACEMENT PIPELINE WAS IMPLANTED SUCCESSFULLY. THE SITE CONSIDERED THE EVENT TO RESULT IN SERIOUS INJURY DUE TO THE FAILURE OF THE PIPELINE TO IMPLANT. HOWEVER, NO ADVERSE PATIENT SYMPTOMS OR OTHER COMPLICATIONS WERE DESCRIBED.

  Patient problems: Failure of Implant

  MAUDE report 18981553 ↗
• MalfunctionMar 5, 2024Activation Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE FAILURE TO OPEN MAY BE THAT THERE WAS SOME PROBLEM WITH THE TIP. AFTER IT WAS PULLED OUT OF THE BODY, IT WAS SLIGHTLY DEFORMED. THE PIPELINE WAS IN A HORIZONTAL SEGMENT WHEN IT FAILED TO OPEN. ADDITIONAL STEPS/DEVICE USED IN ATTEMPT TO OPEN THE PIPELINE INCLUDED THE PUSHWIRE AND CATHETER, PLUS THE INTERMEDIATE CATHETER NAVIEN WERE USED TO RAISE THE SUPPORT. IT STILL COULD NOT BE OPENED AFTER REPEATED ADJUSTMENT OR OPERATION IN OTHER WAYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837586 ↗
• MalfunctionJan 9, 2024Premature Separation; Premature Separation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTHCARE PROVIDER (HCP) COMMUNICATED TO ME THAT THE PUSH WIRE WAS NOT ROTATED DURING ATTEMPTED DEPLOYMENT OF THIS DEVICE. THE PUSH WIRE WAS PULLED BACK DURING ATTEMPTED DEPLOYMENT. DURING INITIAL DEPLOYMENT THE HCP DECIDED TO REPOSITION THE DEVICE. THE PUSH WIRE WAS PULLED BACK FOR RECAPTURE AND REPOSITIONING. THE HCP COMMUNICATED AFTER THIS REPOSITIONING HE THEN ATTEMPTED TO DEPLOY THE DEVICE AGAIN. DURING THE ATTEMPT IS WHEN THE DEVICE CAME OFF THE RE SHEATHING PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480785 ↗
• MalfunctionFeb 15, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING A PIPELINE THAT FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN LICA CC FISTULA. THE LANDING ZONE WAS 3.5 MM DISTALLY AND 4.75 MM PROXIMALLY.  IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED. THE PRU LEVEL WAS 80. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOED THE PIPELINE DEVICE REMOVED AND NOT IMPLANTED. SURPASS EVOLVE IMPLANTED. GOOD ANGIOGRAPHIC RESULT. NO INJURY TO THE PATIENT FROM THIS EVENT. THE PATIENT'S PAST MEDICAL HISTORY INCLUDES SMOKING AND ALCOHOL USE. IT WAS REPORTED THAT THE DOCTOR HAD A PIPELINE SHIELD DEVICE THAT FAILED TO OPEN ON THE DISTAL END DURING A SURGERY ON (B)(6) 2023. THE PATIENT PRESENTED WITH A LEFT INTERNAL CAROTID FISTULA. THE PATIENT WAS PREPPED AND ARTERIAL ACCESS INTO RIGHT FEMORAL ARTERY. A TRACSTAR 088 SHEATH WAS ADVANCED INTO THE LICA. AN SL10 COILING CATHETER WAS ADVANCED INTO THE FISTULA AND THEN A PHENOM 027 CATHETER WAS ADVANCED INTO THE LEFT MCA ARTERY IN PREPARATION FOR PIPELINE DEPLOYMENT. PIPELINE SHIELD 4.75 X 30 WAS SELECTED AND PREPARED PER IFU. PIPELINE WAS ADVANCED INTO THE PHENOM 027 CATHETE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16379771 ↗
• MalfunctionNov 21, 2022Activation Failure; Activation Failure

  NEW INFORMATION WAS RECEIVED. DEVICE INFORMATION FOR THIRD DEVICE: PED2-475-30 LOT# B284190.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835781 ↗

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-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-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-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-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-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