PipelineTM Flex Embolization Device with Shield TechnologyTM PED2-450-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000284534), received between Mar 23, 2023 and Mar 31, 2026 — classified as 1 death, 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Retraction Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN COULD NOT RECAPTURE THE PTFE SLEEVES. HE TRIED ADVANCING THE PHENOM 27 BUT IT WOULD NOT ADVANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED LEFT-SIDED ANEURYSM. IT WAS NOTED THE PATIENT'S VESSEL TO RTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS ACCEPTABLE. 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. ANCILLARY DEVICES INCLUDE A GUIDE CATHETER, RFX058-125-08 AND A PHENOM MICROCATHETER, FG15150-0615-1S. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS NOT DETERMINED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING OF THE DEVICE. THE CATHETER WAS FLUSHED PER THE IFU DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743474 ↗
• MalfunctionMar 30, 2026Material Frayed; Material Separation; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO PIPELINE STENT'S FAILED TO OPEN. THE PATIENT WAS UNDERGOING NEUROINTERVENTIONAL MINIMALLY INVASIVE PROCEDURE WITH BLOOD FLOW-DIVERTING STENT IMPLANTATION FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED LEFT INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY SEGMENT ANEURYSM. IT HAD A MAX DIAMETER OF 4.1 MM AND A 3.7 MM NECK DIAMETER. THE LANDING ZONE WAS 3.3 MM DISTALLY AND 4.3 MM PROXIMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 6.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED WITHIN A NORMAL PLATELET REACTIVITY UNITS (PRU) RANGE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT THE ACCESS WAS ESTABLISHED SMOOTHLY, AND THE PHENOM 27 STENT CATHETER WAS SUCCESSFULLY ADVANCED TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PED2-450-18 WAS FULLY HYDRATED WITH HIGH-PRESSURE SALINE AND DELIVERED INTRACRANIALLY WITHOUT DIFFICULTY. HOWEVER, AFTER APPROXIMATELY 10 MM OF THE STENT WAS EXPOSED, THE TIP END STILL FAILED TO OPEN AND APPEARED MORPHOLOGICALLY ABNORMAL. UNDER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) FLUOROSCOPY, THE BRAIDED WIRES AT THE TIP END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713560 ↗
• MalfunctionMar 2, 2026Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT WERE IDENTIFIED. THERE WAS NO OBSERVED DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER. THE DISTAL SECTION OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. REPEATED ATTEMPTS TO RETRIEVE AND REDEPLOY THE DEVICE WERE PERFORMED, BUT THESE EFFORTS STILL FAILED TO OPEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484241 ↗
• MalfunctionJan 30, 2026Material Frayed; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT HAD BEEN CONFIRMED THAT THE TIP END COULD NOT BE OPENED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN AND ADDITIONAL STEPS OR OTHER DEVICES USED TO ATTEMPT TO OPEN THE PIPELINE INCLUDED DEPLOYING THE DEVICE A FEW TIMES AND UPON FEELING SOMETHING WAS WRONG AT THE TIP END, STOPPED DEPLOYING IT AND DIDN'T TAKE ANY FURTHER ACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226606 ↗
• MalfunctionDec 15, 2025Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO OPEN WAS DETERMINED TO BE RESISTANCE, WHICH OCCURRED IN THE DISTAL SECTION OF THE CATHETER. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE, SUCH AS KINKING, STRETCHING, OR SEPARATION, WAS OBSERVED ON THE PIPELINE PUSHWIRE OR CATHETER.

  Patient problems: Failure of Implant

  MAUDE report 23805084 ↗
• MalfunctionDec 2, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE KINK AND FAILURE TO OPEN WAS NOT DETERMINED. IT WAS CLARIFIED THAT THERE WAS NO THROMBOSIS AT THE KINK SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693571 ↗
• MalfunctionOct 30, 2025Deformation Due to Compressive Stress; Material Deformation; Activation Failure; Deformation Due to Compressive Stress; Material Deformation; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT A PHENOM27 MICROCATHETER WAS POSITIONED AT THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. AFTER ADEQUATE HYDRATION OF THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2), IT WAS DELIVERED VIA THE PHENOM 27 MICROCATHETER, PUSHED TO GO UPPER, AND DELIVERED TO THE TARGET LOCATION. THE TIP OF STENT DEPLOYMENT BEGAN AT THE STRAIGHT SEGMENT OF THE M1; THE STENT DELIVERY GUIDEWIRE WAS KEPT STATIONARY, AND THE MICROCATHETER WAS WITHDRAWN TO DEPLOY THE STENT. AFTER DEPLOYING A CERTAIN LENGTH, THE STENT TIP DID NOT OPEN. FURTHER STENT DEPLOYMENT WAS ATTEMPTED AND APPROPRIATE EXPANSION STILL DID NOT RESULT IN ADEQUATE OPENING. AN ATTEMPT WAS MADE TO FULLY RETRIEVE THE STENT BACK INTO THE PHENOM 27 MICROCATHETER AND RE-DEPLOY APPROXIMATELY 10 MM, BUT THE STENT TIP STILL FAILED TO OPEN. AFTER STABILIZING THE PHENOM 27 AND SLIGHTLY ADVANCING THE STENT DELIVERY GUIDEWIRE, ABOUT ONE-FOURTH OF THE STENT OPENED. AT THIS POINT, FLUOROSCOPY REVEALED EVERSION OF THE STENT TIP. THE SURGEON REPORTED STENT TIP DAMAGE. THE STENT AND PHENOM 27 MICROCATHETER WERE WITHDRAWN TOGETHER FROM THE BODY, AND VISUAL INSPECTION CONFIRMED DAMAGE TO THE STENT TIP. THE MICRO CATHETER AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430223 ↗
• MalfunctionAug 25, 2025Material Deformation; Activation Failure; Material Deformation; Activation Failure

  IT WAS REPORTED THAT A PIPELINE EMBOLIZATION DEVICE WAS USED TO TREAT AN UNRUPTURED ANEURYSM LOCATED AT C5 WITH AMORPHOUS MORPHOLOGY, A MAXIMUM DIAMETER OF 10.2 MM, AND A NECK DIAMETER OF 5.66 MM. THE DISTAL LANDING ZONE WAS 3.5MM AND THE PROXIMAL LANDING ZONE WAS 4.7MM. SEVERE VESSEL TORTUOSITY WAS PRESENT. DURING THE PROCEDURE, THE MIDDLE SECTION OF THE STENT WAS SLIGHTLY KINKED AND COULD NOT BE OPENED, AND THE STENT TIP WAS RIVETED. AFTER RECOVERY AND MICROCATHETER AND INTERMEDIATE CATHETER OPERATION, IT STILL COULD NOT BE OPENED. THE STENT WAS SUBSEQUENTLY REPLACED, AND THE TREATMENT WAS SUCCESSFULLY COMPLETED. ANGIOGRAPHY CONDUCTED POST-PROCEDURE SHOWED SLOW BLOOD FLOW. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22891785 ↗
• MalfunctionApr 28, 2025Structural Problem; Material Twisted/Bent; Activation Failure; Structural Problem; Material Twisted/Bent; Activation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE CAUSE OF THE EVENT AND IT WAS DEEMED THAT THE CAVERNOUS AND OPHTHALMIC SEGMENTS OF THE INTERNAL CAROTID ARTERY (ICA) WERE TOO TORTUOUS TO DEPLOY A PIPELINE DEVICE. THE DEVICE DID NOT HAVE THE ABILITY TO OWN AROUND THE BENDS DESPITE SIGNIFICANT MANIPULATION. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921075 ↗
• MalfunctionFeb 21, 2025Unintended Ejection; Activation Failure; Unintended Ejection; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN IN THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5 MM AND A 6 MM NECK DIAMETER. LANDING ZONE: DISTAL: 12 MM AND PROXIMAL: 11 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET MEDICATION WAS NOT ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL. IT WAS REPORTED THAT DURING THE IMPLANTATION PROCESS, THE TIP END DID NOT OPEN WELL. AFTER SUBSEQUENT ADJUSTMENTS, IT STILL DID NOT OPEN. THE STENT WAS DETACHED AFTER TWO ATTEMPTS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433736 ↗
• MalfunctionFeb 4, 2025Material Deformation; Activation Failure; Physical Resistance/Sticking; Material Deformation; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT TOOK PLACE THE 1ST WEEK OF JANUARY 2025. CHARACTERISTICS OF THE INJURY (LOCATION, SIZE, TYPE, LATERAL, DIMENSION, ETC.): ANEURYSM IN INTERNAL CAROTID BEFORE MIDDLE CEREBRAL BIFURCATION. THE PATIENT¿S VESSEL TORTUOSITY WAS NORMAL. NO PIPELINE FRICTION WAS REPORTED. THE PIPELINE DID NOT ENCOUNTER A JAM OR RESISTANCE IN THE PHENOM CATHETER. THE DEVICE DID NOT DETACH FROM THE PUSHER OR THE PROXIMAL END. THE PIPELINE DID NOT OPEN. THE CAUSE OF THE PUSH WIRE DAMAGE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE WAS OBSERVED ON THE CATHETER. THE PROXIMAL END OF THE PIPELINE DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A BEND OF A VESSEL WHEN IT DID NOT OPEN. NO ADDITIONAL STEPS OR OTHER DEVICES WERE ATTEMPTED TO OPEN THE PIPELINE. NO DAMAGE WAS OBSERVED ON THE PUSH WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306799 ↗
• MalfunctionJan 15, 2025Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE FLEX WITH SHIELD (PED2) STENT THAT FAILED TO OPEN AT THE DISTAL END. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) C6 SEGMENT UNRUPTURED SACCULAR ANEURYSM. PATIENT VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CATHETER DELIVERY SYSTEM WAS NAVIGATED TO THE M1 SEGMENT WITH THE GUIDEWIRE AND THE GUIDEWIRE WAS WITHDRAWN. AFTER PREPARATION AND HYDRATION OF THE PIPELINE, IT WAS DELIVERED AND DEPLOYMENT WAS INITIATED. WHEN ABOUT 7MM OF THE PIPELINE WAS DEPLOYED, IT WAS FOUND THAT THE DISTAL TIP COULD NOT BE OPENED. THE Y-VALVE WAS LOCKED TIGHTLY AND THE SURGEON WAITED 3 MINUTES BUT THE PIPELINE TIP STILL WAS NOT OPENED. THE PIPELINE STENT WAS RESHEATHED AND REDEPLOYED BUT THE DISTAL END STILL DID NOT OPEN. PUSHING AND PULLING WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A VESSEL BEND AND MORE THAN 50% OF THE PIPELINE WAS DEPLOYED WHEN THE FAILURE TO OPEN WAS OBSERVED. THE PIPELINE WAS RETRIEVED AND REPLACED WITH THE NEXT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160930 ↗
• InjuryDec 20, 2024Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT A PATIENT TREATED WITH A PED2 PIPELINE, PHENOM PLUS CATHETER, AND PHENOM 27 CATHETER HAD ENHANCING BRAIN LESIONS. THE EVENT REQUIRED A NEW HOSPITALIZATION ON (B)(6) 2024. TREATED WITH SURGICAL PROCEDURE. THE EVENT IS NOT RECOVERED. THE PATIENT WAS ORIGINALLY TREATED FOR AN ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA), C7 SEGMENT. ANEURYSM MORPHOLOGY: SACCULAR. MAXIMUM ANEURYSM DIAMETER: 7.3MM. ANEURYSM DOME HEIGHT: 6.2MM. ANEURYSM DOME WIDTH: 6.8MM. ANEURYSM NECK SIZE: 2.4MM. PARENT ARTERY DIAMETER DISTAL TO ANEURYSM: 3.5MM. PARENT ARTERY DIAMETER PROXIMAL TO ANEURYSM: 4.4MM. COMPLETE STASIS AT THE END OF THE PROCEDURE.

  Patient problems: Aneurysm; Bacterial Infection; Bruise/Contusion; Foreign Body Reaction; Granuloma; Headache; Hemorrhage/Blood Loss/Bleeding; Impaired Healing; Nervous System Injury; Paresthesia; Skin Discoloration; Transient Ischemic Attack

  MAUDE report 20994079 ↗
• DeathOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ADVERSE EVENT WAS NOT THE RESULT OF A DEVICE DEFICIENCY. THE SITE ASSESSED THE EVENT AS NOT RELATED TO A RETREATMENT PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Ischemia Stroke; Numbness; Syncope/Fainting; Thrombosis/Thrombus

  MAUDE report 20575608 ↗
• MalfunctionMar 14, 2024Retraction Problem; Activation Failure; Physical Resistance/Sticking; Retraction Problem; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE TIP END OF THE STENT BEING STUCK IN THE MICROCATHETER UNDETERMINED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902836 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DISEASE UNDER STUDY, THE DEVICE, AND THE PROCEDURE. THE PATIENT HAD BEEN TREATED FOR A SACCULAR, SIDEWALL ANEURYSM LOCATED IN THE C2 SEGMENT.

  Patient problems: Paresthesia; Skin Discoloration; Transient Ischemic Attack

  MAUDE report 17822408 ↗
• MalfunctionSep 25, 2023Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A PED2 PIPELINE STENT FAILED TO OPEN IN THE DISTAL SECTION. THE PIPELINE WAS PREPPED AND READY TO DELIVER BUT DISTAL END OF THE DEVICE DID NOT OPEN CORRECTLY. TRIED RESHEATHING ONCE AND REMOVED FROM BODY. PROCEDURE COMPLETED WITH SECOND DEVICE, NO ISSUES WITH DEPLOYING OTHER DEVICE. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED LESS THAN OR EQUAL TO 2 TIMES. THE PIPELINE WAS RESHEATHED AND REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 12MM AND THE NECK DIAMETER WAS 6MM. THE DISTAL LANDING WAS 4.5MM AND THE PROXIMAL LANDING ZONE WAS 4.5MM. VESSEL TORTUOSITY WAS SEVERE. ANGIOGRAPHIC RESULT POST PROCEDURE WAS EXCELLENT.  NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814866 ↗
• InjuryMar 23, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Migration; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED LESION CHARACTERISTICS: TERMINUS, LOBULATED, 12MM, RIGHT C7. THE PATIENT WAS DISCHARGED TO HOME, ALERT, FULLY ORIENTED X3, HAS A FOLLOW-UP IN A FEW WEEKS. THE PATIENT WAS GIVEN IVF, WORKED WITH PHYSICAL THERAPY, AND GIVEN SCRIPT FOR OUTPATIENT THERAPY.

  Patient problems: Headache; Muscle Weakness/Atrophy; Stroke/CVA; Thromboembolism; Transient Ischemic Attack; Unspecified Nervous System Problem

  MAUDE report 16598383 ↗

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-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-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-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