PIPELINE PED-400-25 (UDI 00847536015968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847536015968), received between Apr 11, 2017 and Mar 30, 2022 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 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.

Recalls naming this device

1. Jul 13, 2021Class IOpen, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE COULD NOT BE OPENED IN THE BLOOD VESSEL AND THE STENT WAS DIFFICULT TO WITHDRAW FROM THE CATHETER. THE RESISTANCE WAS IN THE MIDDLE SECTION. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE. THE CATHETER NOR THE PUSHWIRE WERE DAMAGED. THE PIPELINE WAS NOT USED OFF-LABEL AND THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 13MM AND A 8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. A DAPT WAS ADMINISTERED BUT THE PRU LEVEL WAS UNKNOWN. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED INTERNAL CAROTID ANEURYSM. ANCILLARY DEVICES INCLUDE: 6F 115 NAVIEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956659 ↗
• MalfunctionAug 9, 2021Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 2021-AUG-11. IT WAS REPORTED THAT THERE WAS RESISTANCE AND COULD NOT BE DEPLOYED. THE RESISTANCE OCCURRED DURING DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12295166 ↗
• MalfunctionMay 21, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PIPELINE WAS PLACED IN A STRAIGHT SEGMENT OF THE BLOOD VESSEL WHEN IT FAILED TO OPEN. RE-SHEATHING HAD BEEN PERFORMED ONE TIME, AND NO ADDITIONAL STEPS OR OTHER DEVICES WERE USED IN AN ATTEMPT TO OPEN THE STENT. IT WAS CLARIFIED THAT THE "PIPELINE TIP COULD NOT BE RIVETED" WAS REFERRING TO THE DISTAL END FAILING TO OPEN, AND "STENT'S TIP WAS OBSERVED BURR DEFORMATION" REFERRED TO DAMAGE TO THE TIP OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11862246 ↗
• MalfunctionApr 16, 2021Material Deformation; Activation Failure; Material Deformation; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679403 ↗
• MalfunctionNov 19, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE PIPELINE STENT COULD NOT BE OPENED AFTER REPEATED ATTEMPTS. THE STENT WAS NOT POSITIONED IN A BEND, MORE THAN 50% WAS DEPLOYED, RESHEATHING WAS PERFORMED MORE THAN TWICE, AND NO ADDITIONAL STEPS WERE TAKEN IN AN ATTEMPT TO OPEN THE DEVICE. THE MARKSMAN MICROCATHETER AND STENT WERE WITHDRAWN TOGETHER AND STUCK TOGETHER. IT WAS DIFFICULT TO REMOVE THE PIPELINE FROM THE BODY OF THE MICROCATHETER. REPLACEMENT PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED/FLUSHED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED SLOW BLOOD FLOW. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 1.96 MM AND A 8.97 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL REACHED THE STANDARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10868755 ↗
• MalfunctionAug 25, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE STENT DEPLOYED IN THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR INTRACRANIAL BLOOD FLOW GUIDED DEVICE IMPLANTATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE STENT WAS DEPLOYED FOR THE FIRST TIME, BUT THE POSITION WAS NOT IDEAL. THE PHYSICIAN RETRIEVED THE STENT TO REDEPLOY, BUT THE STENT BECAME DISLODGED IN THE DISTAL SEGMENT OF THE CATHETER. THERE WAS NO DAMAGE NOTED TO THE CATHETER OR PUSHWIRE, AND A CONTINUOUS FLUSH HAD BEEN USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT THE PIPELINE SEPARATED FROM THE DELIVERY SYSTEM WITHIN THE CATHETER. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANY TIME DURING THE PROCEDURE. THE DEVICE AND CATHETER WERE REMOVED TOGETHER AND A NEW CATHETER AND STENT WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10450960 ↗
• MalfunctionFeb 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT PIPELINE FLEX (PED) ENCOUNTERED RESISTANCE AT THE DISTAL AND MIDDLE SECTION OF THE CATHETER. THE PED TIP WAS THE ONLY THING THAT EXITED THE CATHETER TIP. AFTER REPEATED ATTEMPTS, IT COULD ONLY BE WITHDRAWN. WHEN TESTED OUT OF THE BODY, IT COULDN'T BE RETRIEVED AND RELEASED. THERE WAS NO DAMAGE TO THE DEVICES. THE DEVICES WERE USED PER THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED. NO PATIENT INJURY OCCURRED. THE VESSEL ANATOMY WAS MINIMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9694706 ↗
• InjuryFeb 10, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE EMBOLIZATION PROCEDURE, THE PATIENT EXPERIENCED VASOSPASMS. NIMODIPINE WAS ADMINISTERED FOR 10 MINUTES TO TREAT THE VASOSPASM. THE PROCEDURE WAS COMPLETED VIA STENT ASSISTED COILING. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED, SACCULAR INTERNAL CAROTID ARTERY ANEURYSM. MEASURING 5.5 MM X 6 MM, LANDING ZONE DISTAL 3.9 MM PROXIMAL 3.7 MM. THE VESSEL ANATOMY WAS MODERATELY TORTUOUS.

  Patient problems: Vasoconstriction

  MAUDE report 9686438 ↗
• InjuryJan 7, 2020Break; Break

  ADDITIONAL INFORMATION: NO, THE PUSHWIRE DID NOT TAKE OUT, USED SOLITAIRE FR TO TAKE IT OUT TWICE BUT FAILED, SO GAVE UP. THERE WERE NO ANY ACTIONS/INTERVENTIONS PLANNED TO REMOVE THE BROKEN DEVICE, BECAUSE THE BLOOD FLOW WAS NORMAL AFTER THE SURGERY. NOT ANY IMAGES AVAILABLE FOR REVIEW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9557946 ↗
• MalfunctionJan 6, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX STENT WAS RELEASED COMPLETELY, THE MARKSMAN MICROCATHETER RETRIEVED THE TIP OF GUIDEWIRE, THE TIP OF THE GUIDE WIRE WAS BROKEN, THE OPERATOR SLOWLY WITHDREW THE MICROCATHETER AND THE GUIDEWIRE TOGETHER, AND THE STENT AND GUIDE WIRE WERE REMOVED. THE PUSHWIRE WAS BROKEN AT THE DISTAL END. THERE WAS NO FRICTION OR DIFFICULTY. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF OPHTHALMIC ARTERY SEGMENT, UNRUPTURED ANEURYSM, THAT WAS SACCULAR. THE MAX DIAMETER WAS 15MM AND NECK WAS 7MM. THE DISTAL LANDING ZONE WAS 3.6MM AND THE PROXIMAL WAS 4MM. THE VESSEL ANATOMY WAS MINIMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553044 ↗
• InjuryDec 26, 2019Break; Break

  MEDTRONIC RECEIVED REPORT THAT THE DISTAL SEGMENT OF THE PIPELINE FLEX DELIVERY SYSTEM SEPARATED WITHIN THE TREATING VESSEL. THE SEPARATED DISTAL SEGMENT WAS UNABLE TO BE RETRIEVED. DURING THE RELEASE OF THE STENT, THE TIP OF COIL AND PART OF THE PUSHING GUIDE WIRE WERE DISCONNECTED FROM THE PUSHING ROD. THE STENT AND THE TIP OF DEVELOPMENT GUIDE WIRE AND PART OF THE PUSHING GUIDE WIRE REMAINED IN THE BODY, WHICH COULDN'T BE REMOVED. THE SURGEON TRIED TO REMOVE THE BROKEN GUIDE WIRE WITH A GOOSENECK DEVICE AND SAB, A NEUROVASCULAR REMODELING DEVICE, BUT FAILED. RELEASED THE SAB TO COVER THE GUIDE WIRE, AND RELEASED A BLOOD FLOW GUIDE EMBOLISM DEVICE PED, SUCCESSFULLY COVERED THE ANEURYSM NECK, ANEURYSM RETENTION. THE PATIENT WAS ASYMPTOMATIC POST THE INTERVENTION. THIS EVENT OCCURRED DURING THE TREATMENT OF A C4, LEFT INTERNAL NECK ANEURYSM. THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 20MM AND THE NECK WAS 8MM. THE DISTAL LANDING ZONE WAS 3.OMM AND THE PROXIMAL WAS 3.5MM. THE VESSEL ANATOMY WAS MINIMAL IN TORTUOSITY. ANCILLARY DEVICES: 6FR LONG SHEATH, 6FNAVIEN115, MARKSMAN150; THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9522099 ↗
• MalfunctionSep 9, 2019Activation Failure; Activation Failure

  CRUSHED/KINKED/DAMAGED. LESS THAN 50% OF THE PIPELINE DEPLOYED, LESS THAN 2 RESHEATHING ATTEMPTS WERE MADE. AS A RESULT THE PIPELINE WAS REPLACED WITH THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT SIDE ANEURYSM WITH A MAX DIAMETER OF 1.6MM AND A NECK DIAMETER OF 6.15MM. IT IS UNKNOWN IF THE DEVICE WAS PREPARED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. POST PROCEDURE ANGIOGRAPHIC RESULTS WERE GOOD. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976930 ↗
• MalfunctionJun 9, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT, DURING RELEASE, THE PIPELINE COULD NOT OPEN AND WAS IN THE SHAPE OF A "BAR." THROUGH CONTINUOUS MASSAGE AND USING THE EXPERIENCE OF THE PHYSICIAN THEY WERE ABLE TO OPEN THE MIDDLE SECTION, BUT THE TIP REMAINED CLOSED. AS A RESULT THE PIPELINE WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. IT WAS STATED THAT THIS WAS PART OF A TEACHING CASE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS ANEURYSM WITH A MAX AND NECK DIAMETER OF 3.9 MM. IT WAS NOTED THAT THE VESSEL TORTUOSITY WAS MODERATE. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED NO DAMAGE, BUT FURTHER OBSERVATION IS NEEDED. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. LESS THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN, AND LESS THAN OR EQUAL TO 2 ATTEMPTS WERE MADE TO RESHEATH THE DEVICE. THE PIPELINE WAS NOT PLACED IN BEND, PIPELINE WAS RELEASED FROM THE HORIZONTAL SECTION, BUT THIS SECTION OF THE BLOOD VESSEL ITSELF HAD MORE CURVATURE AND IS COMBINED WITH A STENOSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8681388 ↗
• MalfunctionJun 6, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF THE PIPELINE COULD NOT BE OPENED, EVEN AFTER MULTIPLE ADJUSTMENTS. THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 12MM AND A NECK DIAMETER OF 8MM. IT WAS NOTED THAT THE PATIENT HAD A MINIMAL VESSEL TORTUOSITY. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THE PIPELINES WERE NOT PLACED IN THE BEND. POST PROCEDURE ANGIOGRAPHIC RESULTS SHOWED "PARTIAL REMAIN." THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8676948 ↗
• InjuryApr 3, 2019Positioning Problem; Positioning Problem

  MEDTRONIC RECEIVED INFORMATION A REPORT OF PIPELINE FLEX MOVEMENT DURING PLACEMENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANEURYSM LOCATED IN OPHTHALMIC SEGMENT, MEASURING 8MMX5MM, LANDING ZONE DISTAL 2.7MM PROXIMAL 3.9MM. THE VESSEL WAS OBSERVED SEVERELY TORTUOUS. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. IT WAS REPORTED THAT THIS WAS A LEFT PARA OPHTHALMIC SEGMENT ANEURYSM PLANNED FOR FLOW DIVERTER. THE MICROCATHETER WAS PLACED IN THE DISTAL M2 BRANCH AND PIPELINE 4X25 WAS TAKEN THROUGH AND STARTED DEPLOYING JUST BELOW THE ICA BIFURCATION. THE DISTAL LANDING WAS CORRECT AS PER THE PLAN JUST BELOW THE ICA BIFURCATION. CONTINUED TO DEPLOY THE DEVICE SLOWLY, WHILE DEVICE STARTED TO OPEN AT THE NECK OF THE ANEURYSM, THE DISTAL DEVICE HAS FALLEN NO ADEQUATE SUPPORT OF DEVICE WAS THERE ABOVE ANEURYSM NECK. SO PHYSICIAN DECIDED TO RESHEATH THE DEVICE. WHILE RESHEATHING THE MICROCATHETER ALONG WITH DEVICE SUDDENLY JUMPED INTO DISTAL M2 SEGMENT. WHEN PHYSICIAN TRIED TO RETRIEVE THE DEVICE INTO MICROCATHETER, ONLY DELIVERY WIRE OF THE DEVICE WAS SEEN MOVING INTO MICROCATHETER AND NO MOVEMENT IN THE DEVICE. NOW PHYSICIAN HAD TRIED TO PULL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480623 ↗
• MalfunctionApr 1, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX PUSHWIRE BREAK. THE PATIENT WAS UNDERGOING PIPELINE FLEX PLACEMENT IN THE TREATMENT OF A SMALL UNRUPTURED SACCULAR RIGHT INTERNAL CAROTID ARTERY ANEURYSM, MEASURING 7MMX3MM, LANDING ZONE DISTAL 3.9MM, PROXIMAL 4.0MM. THE VESSEL WAS NORMAL TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX BECAME STUCK IN THE MICROCATHETER. THE PIPELINE COULD NOT BE PUSHED FRMO THE MICROCATHETER, LEADING TO STENT AND EWIRE CRACKED. THE STENT WAS RELEASED IN MICROCATHETER AND THEN WITHDRAWN FROM THE PATIENT. THE BROKEN SEGMENT OF THE PUSHWIRE REMOVED FROM THE PATIENT. THERE WAS REPORTEDLY NO DAMAGE TO THE CATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471341 ↗
• InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS PATIENT'S MASS EFFECT WORSENED, APPROXIMATELY 5 WEEKS POST PIPELINE TREATMENT. IT WAS FURTHER REPORTED THAT THIS PATIENT DEVELOPED A SUBARACHNOID HEMORRHAGE (SAH) WITHIN THE PIPELINE TREATMENT AREA APPROXIMATELY 5 MONTHS POST PROCEDURE, BUT THE PATIENT WAS CONFIRMED TO HAVE RECOVERED THE SAME DAY. IN ADDITION, VISUAL NERVE INDICATION POST PROCEDURE WAS NOTED TO HAVE ALSO WORSENED. THE PATIENT RECEIVED A CHANGE IN MEDICATION. IT WAS FURTHER NOTED THAT THE PHYSICIAN DID NOT BELIEVE THE SAH AND MASS EFFECT WERE ASSOCIATED WITH THE PROCEDURE NOR WITH THE USE OF THE PIPELINE. ANEURYSM TREATED WAS LOCATED IN THE PARACLINOID SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY. THE ANEURYSM WAS UNRUPTURED, FUSIFORM, SIZE: MAX DIAMETER 17.0 MM, NECK WIDTH NOT MEASURED.

  Patient problems: Edema; Hemorrhage, Subarachnoid; Neurological Deficit/Dysfunction

  MAUDE report 6483711 ↗

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-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-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-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