PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000284572), received between Dec 22, 2023 and Apr 27, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT COULD NOT BE OPENED. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, CAVERNOUS SEGMENT ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.5 MM AND A 8 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4 MM DISTALLY AND 4.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PLATELET REACTIVITY UNIT (PRU) LEVEL WAS NOTED AS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED CAVERNOUS SEGMENT ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY. AFTER OPENING THE PACKAGE AND HYDRATING THE STENT, THE STENT WAS DELIVERED. HOWEVER, THE TIP END OF THE STENT COULD NOT BE OPENED DURING DEPLOYMENT, AND MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. THE STENT WAS REPLACED WITH A MEDTRONIC PRODUCT, AND THE PROCEDURE WAS COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED THE PIPELINE WAS USED FOR AN APPROVED INDICATION (O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999977 ↗
• MalfunctionMar 13, 2026Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT RESISTANCE OCCURRED WHEN THE STENT WAS DELIVERED TO THE MID-TO-DISTAL SEGMENT OF THE CATHETER. THERE WERE NO DAMAGES OBSERVED ON THE PIPELINE PUSH WIRE OR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597952 ↗
• MalfunctionJan 30, 2026Positioning Failure; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE WAS PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE AND RE-DEPLOY THE STENT, BUT THE CAUSE OF THE FAILURE TO OPEN WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY NOTED DURING DELIVERY OR POSITIONING, AND THE DEVICE DID NOT JUMP DURING DEPLOYMENT. HOWEVER, THE TIP OF THE CATHETER DID MOVE DURING DEPLOYMENT. THE NAVIEN CATHETER USED WAS MODEL 5F115, AND THE MARKSMAN WAS 150CM IN LENGTH, THOUGH THE LOT NUMBER WAS UNKNOWN. IT WAS CLARIFIED THAT "THE STABILITY OF THE ENTIRE SYSTEM WAS EXTREMELY POOR" REFERS TO THE BLOOD VESSELS BEING TOO TORTUOUS TO PROVIDE ADEQUATE SUPPORT FOR STENT DEPLOYMENT, MAKING IT DIFFICULT TO OPERATE AND TRANSMIT FORCE DURING PUSHING AND PULLING MANEUVERS ON THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222556 ↗
• MalfunctionJan 12, 2026Material Deformation; Material Twisted/Bent; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT INTERNAL CAROTID ARTERY INTRACRANIAL ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4 MM NECK DIAMETER. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7MM DIAMETER. THE LANDING ZONE WAS 4MM DISTALLY AND 4.5MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN.  IT WAS REPORTED THAT THE OPERATOR SELECTED A SHIELD FLOW DIVERTER STENT. AFTER THE ACCESS WAS ESTABLISHED, THE STENT WAS DELIVERED TO THE IPSILATERAL M1 SEGMENT. AFTER EXPOSING APPROXIMATELY 7¿8 MM OF THE STENT TIP AND WAITING FOR ABOUT 10 SECONDS, THE PED TIP DID NOT OPEN. THE OPERATOR CONTINUED TO DEPLOY AN ADDITIONAL 12 MM, BUT THE TIP STILL FAILED TO OPEN. ATTEMPTS WERE MADE TO RETRIEVE AND REDEPLOY THE STENT, INCLUDING SHAKING, PUSHING, AND PULLING MANEUVERS, BUT THE TIP STILL COULD NOT BE OPENED. ADJUSTING THE PHENOM 21 MICROCATHETER TENSION ALSO DID NOT RESOLVE THE ISSUE. THE STENT WAS SUBSEQUENTLY WITHDRAWN FROM THE BODY, AND IT WAS FOUND THAT THE STENT TIP WASINTERTWINED. CONCERNED ABOUT POSSIBLE DAMAGE TO THE STENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037366 ↗
• MalfunctionDec 22, 2025Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT DURING DEPLOYMENT, THE DELIVERY SYSTEM DID NOT MOVE, HOWEVER, THE PIPELINE STENT JUMPED AND FELL DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872752 ↗
• MalfunctionDec 12, 2025Positioning Failure; Difficult to Advance; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Positioning Failure; Difficult to Advance; Material Deformation; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE MICROCATHETER WAS IN POSITION, THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) WAS DELIVERED, THE TIP WAS OPENED AND ANCHORED, AND STENT DEPLOYMENT CONTINUED, HOWEVER, THE MIDDLE SECTION OF THE STENT FAILED TO OPEN. REPEATED ATTEMPTS WERE MADE TO PUSH AND PULL IT. THE TIP OF THE STENT, ALONG WITH THE MICROCATHETER, THEN FELL INTO THE ANEURYSM CAVITY, SO DEPLOYMENT WAS NO LONGER POSSIBLE. THE STENT AND MICROCATHETER WERE WITHDRAWN, AND IT WAS OBSERVED THAT THE TIP OF THE STENT WAS ROUGH AND DEFORMED. THE STENT AND MICROCATHETER WERE 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, CAVERNOUS SINUS SEGMENT ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 6 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 4.5 MM DISTALLY AND 4.7 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD STAGNATION WITHIN THE ANEURYSM. VASCULAR ACCESS WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796830 ↗
• MalfunctionJul 29, 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 RIGHT C7-C4 SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3.9MM AND A 4MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE LANDING ZONE WAS 3.7MM DISTALLY AND 4.4MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS ZERO (0). IT WAS REPORTED THAT DURING THE DELIVERY OF THE PIPELINE PED STENT AND THE DEPLOYMENT; THE TIP END OF THE STENT DID NOT OPEN PROPERLY. IT WAS FOUND THE TIP END TO BE DAMAGED WHEN IT WAS REMOVED FROM THE BODY. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647128 ↗
• MalfunctionFeb 24, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO KINK OCCURRED. THE PIPELINE DID NOT OPEN IN THE MIDDLE SECTION. THE PIPELINE HAD BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THE PHYSICIAN HAD RETRIEVED IT TO DEPLOY AGAIN, BUT THE STENT STILL DID NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21446729 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE DEVICES WERE PREPARED PER THE IFU. THE STROKE WAS MENTIONED AND NOTHING WAS ATTRIBUTED TO IT. THE PATIENT IS STILL IN THE HOSPITAL AND DID EXPERIENCE A BLEED PER THE NEUROSURGERY FELLOW.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke

  MAUDE report 19055142 ↗
• MalfunctionDec 28, 2023Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN AND WAS STUCK AT THE CATHETER HUB. THE PATIENT WAS UNDERGOING NEURO-INTERVENTION, BLOOD FLOW GUIDING DENSE MESH STENT IMPLANTATION FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 8.6 MM AND A 7.1 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.76 MM AND PROXIMAL 4.28 MM. THE ACCESSED VESSEL WAS THE RADIAL ARTERY WITH A DIAMETER OF 2.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS WITHIN THE NORMAL VALUE RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THE BLOOD VESSELS WERE SMOOTH AND EVERYTHING WAS NORMAL. IT WAS REPORTED THAT RADIAL ARTERY PUNCTURE, TETHYS 115 REACHED THE LEVEL OF THE CAVERNOUS SINUS, AND PHENOM 27 WENT AS FAR AS MIDDLE CEREBRAL ARTERY M2. PED2-450-35 WAS DELIVERED SMOOTHLY, M1 SEGMENT OF MIDDLE CEREBRAL ARTERY WAS OPENED, AND THE DEPLOYMENT WAS MORE THAN 15MM, BUT THE PED TIP STILL COULD NOT BE OPENED WELL.  AFTER WAITING, IT OPENED SLIGHTLY, BUT THE SHAPE OF THE TIP DIDN'T LOOK VERY NORMAL. PULLED IT BACK AND POSITIONED AND FOUND THAT THE SHAPE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414402 ↗
• InjuryDec 22, 2023Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Unintended Movement; Activation Failure; Physical Resistance/Sticking; Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS LATER BROUGHT TO GET AN ANGIOGRAM. THE GIANT ANEURYSM HAD RAPIDLY THROMBOSED, ALSO THROMBOSING THE M1. THE PATIENT SUFFERED A LARGE MCA TERRITORY INFARCT. THE PATIENT EXPERIENCED APHASIA AND HEMIPARESIS RELATED TO THE HEMORRHAGE. IN TRADITIONAL DEPLOYMENT THE TIP COIL ADVANCES AS THE DEVICE OPENS, THE TIP COIL STAYED AT THE DISTAL BRAID NEVER ADVANCING, THERE WAS FRICTION ASSOCIATED WITH THIS EVENT.

  Patient problems: Decreased Level of Consciousness; Fatigue; Hydrocephalus; Intracranial Hemorrhage; Ischemia Stroke; Paresis; Speech Disorder; Swelling/ Edema

  MAUDE report 18386668 ↗

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-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