PIPELINE PED-400-20 (UDI 00847536015937)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847536015937), received between Mar 8, 2019 and Jun 29, 2021 — classified as 1 death, 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Recalls naming this device

1. Jul 13, 2021Open, 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A PIPELINE THAT BECAME STUCK AT THE DISTAL END OF THE MARKSMAN CATHETER DURING DEPLOYMENT. THE PATIENT WITH MULTIPLE ANEURYSMS OF THE LEFT CAVERNOUS SINUS SEGMENT WAS UNDERGOING A FLOW DIVERSION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM WITH MAX DIAMETER OF 4.11MM AND NECK DIAMETER OF 3.35MM. VESSELTORTUOSITY WAS MINIMAL.  IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AND THE CATHETER FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE MARKSMAN MICROCATHETER WAS IN PLACED AND THE PIPELINE WAS DELIVERED SMOOTHLY. DEPLOYMENT WAS INITIATED AND THE TIP OF THE PIPELINE OPENED SMOOTHLY AND WAS POSITIONED WELL FOR CONTINUED DEPLOYMENT. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE SECOND HALF OF THE PIPELINE, IT WAS FOUND THE PIPELINE SUDDENLY BECAME STUCK AND COULD NOT BE DELIVERED OR RETRIEVED. MANY ADJUSTMENTS AND REPEATED ATTEMPTS FAILED TO RESOLVE THE ISSUE SO THE SYSTEM WAS WITHDRAWN TOGETHER. BOTH THE PIPELINE AND THE MARKSMAN CATHETER WERE THEN REPLACED AND THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.  ANCILLARY DEVICES: COOK 6F SHEATH, NAVIEN 5F CATHETER, TRAXCESS 0.014 GUIDEWIRE ADDITI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089422 ↗
• MalfunctionJun 7, 2021Activation Failure; Activation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISTAL PART OF THE PIPELINE FAILED TO OPEN. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND AT THE TIME. IT WAS UNKNOWN HOW MANY TIMES THE PIPELINE HAD BEEN RESHEATHED, BUT IT WAS TRIED TO BE DEPLOYED SEVERAL TIMES DURING THE DEPLOYMENT PROCESS. THE SURGEON HAD TRIED TO ADJUST THE DELIVERY MICROCATHETER MANY TIMES, INCREASING AND DECREASING THE TENSION, BUT THE DEVICE COULD NOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946353 ↗
• MalfunctionJun 1, 2021Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION REGARDING THREE PIPELINE DEVICES THAT HAD MOVEMENT DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING A PROCEDURE FOR FLOW DIVERSION TREATMENT OF AN UNRUPTURED AMORPHOUS ANEURYSM OF THE RIGHT POSTERIOR AND OPHTHALMIC ARTERIES. THE ANEURYSM MAX DIAMETER WAS 6.25MM AND THE NECK DIAMETER WAS 6MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PIPELINE DEVICES AND ALL ACCESSORIES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WAS NO FRICTION DURING DELIVERY OF THE DEVICE. DURING DEPLOYMENT THE PIPELINE JUMPED AND FELL BACK, MISSING THE LANDING ZONE. IT WAS NOTED THE PIPELINE WAS PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE AND THE CATHETER TIP WAS MOVED DURING DEPLOYMENT. THE ISSUE OCCURRED WITH THREE DIFFERENT PIPELINE DEVICES; THE FIRST HAD TO BE RECAPTURED USING CORKING TECHNIQUE, THE OTHER TWO PIPELINES DID NOT REQUIRE ADDITIONAL DEVICES OR TECHNIQUES FOR SAFE REMOVAL. NONE OF THE COMPLAINT PIPELINE DEVICES WERE IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11914518 ↗
• MalfunctionMay 3, 2021Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE MOVED DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 6MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 2.2MM DISTAL AND 3.9MM PROXIMAL. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 83. IT WAS REPORTED THAT THE PIPELINE SLID BACK SHORT OF INTENDED LANDING ZONE. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE DEVICE BUT COULD NOT. THE PIPELINE WAS REMOVED AND REPLACED. THERE HAD NOT BEEN ANY FRICTION OR DIFFICULTY DURING DELIVERY OR POSITIONING, AND MULTIPLE PIPELINE DEVICES WERE NOT BEING USED AT THE TIME. THE CORKING TECHNIQUE WAS USED TO REMOVE THE PIPELINE, BUT NO ADDITIONAL DEVICES WERE USED TO REMOVE THE IT. IT WAS NOTED THAT THE PIPELINE HAD JUMPED DURING DEPLOYMENT. THE PIPELINE HAD BEEN PLACED AT LEAST 3MM PAST THE ANEURYSM NECK ON EACH SIDE, AND NO SIDE BRANCHES WERE COVERED BY THE DEVICE. THE TIP OF THE CATHETER HAD BEEN MOVED DURING DEPLOYMENT. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED STASIS IN THE ANEURYSM AND A PATENT PARENT VESSEL. THE PATIENT DID NOT EXPERIENCE ANY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11766733 ↗
• InjuryJan 5, 2021Break; Unintended Ejection; Activation Failure; Break; Unintended Ejection; Activation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A BROKEN PIPELINE PUSHWIRE. THE PATIENT WAS BEING TREATED WITH FLOW DIVERSION ASSISTED COILING FOR AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT ANTERIOR CHOROIDAL AND LEFT POSTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS BEING DEPLOYED AND WAS ANCHORED DISTALLY AT THE TERMINUS OF THE INTERNAL CAROTID ARTERY. THE MIDDLE PORTION OF THE PIPELINE WAS POSITIONED IN A VESSEL BEND. WHEN THE PIPELINE WAS 75% DEPLOYED AND THE MICROCATHETER WAS BETWEEN THE ANTERIOR AND POSTERIOR GENU, IT WAS NOTED THAT MIDDLE SECTION OF THE PIPELINE WAS NOT OPENED WELL SO WAGGING WAS PERFORMED. DURING THE WAGGING, THE PIPELINE DEPLOYED COMPLETELY BEFORE THE MICROCATHETER WAS PULLED BACK PROXIMAL SO THOUGH THE PIPELINE WAS DEPLOYED, IT WAS NOT FULLY UNSHEATHED, IT WAS STILL WITHIN THE SHEATH 3-4MM. DESPITE EARLY DEPLOYMENT, THE DEVICE WAS FULLY OPENED AND APPEARED TO BE POSITIONED WELL. WHILE ATTEMPTING TO RESHEATH THE DELIVERY SYSTE

  Patient problems: Fistula

  MAUDE report 11118567 ↗
• MalfunctionJan 4, 2021Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking; Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DELIVERY SYSTEM BECAME STUCK DURING RETRACTION AND THE PUSHWIRE WAS FOUND TO BE BROKEN AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT PARAOPTHALMIC ARTERY. THE MAX DIAMETER WAS 5 MM, AND THE NECK DIAMETER WAS 4 MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT HAD BEEN ADMINISTERED, AND THE PRU LEVEL WAS 8. THE LANDING ZONE WAS 3.2 MM DISTAL AND 3.8 MM PROXIMAL. THE ACCESS VESSEL WAS RADIAL AND 3 MM IN DIAMETER. IT WAS REPORTED THAT THE PIPELINE PTFE SLEEVES CAUGHT INSIDE DISTAL NAVIEN. THEY COULD NOT PULL PIPELINE WIRE OUT THROUGH NAVIEN, AND THEY HAD TO CORK PIPELINE WIRE AND PULL ENTIRE SYSTEM OUT. UPON EVALUATION THE PIPELINE WIRE SEPARATED FROM WIRE AT PROXIMAL POINT OF NO RETURN. THE PUSHWIRE/CAPTURE COIL WAS STUCK DURING RETRACTION. THE PUSHWIRE WAS ROTATED DURING REMOVAL. THERE WAS NO DAMAGE TO THE CATHETER, BUT THE PUSHWIRE WAS BROKEN AND DETACHED AT THE HYPOTUBE PROXIMAL TO THE WIRE WELD. THE BROKEN SEGMENT WAS REMOVED FROM THE PATIENT THROUGH THE CATHETER. THERE WERE NO ISSUES WITH THE ACTUAL PIPELINE DEPLOYME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114405 ↗
• MalfunctionDec 2, 2020Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN NOTED THAT THE RESISTANCE WAS FELT APPROXIMATELY 20CM FROM THE DISTAL END OF THE CATHETER. THERE WAS NO DAMAGE TO THE PIPELINE OR CATHETER. THE PIPELINE COULD NOT BE OPENED IN A STRAIGHT PART OFTHE VESSEL, EVEN AFTER ATTEMPTS TO MOVE IT BACKWARD AND FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10935594 ↗
• DeathSep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO DEPLOYING 3 PIPELINE DEVICES, 2 OTHER PIPELINE WERE ATTEMPTED TO BE DEPLOYED BUT ENCOUNTERED A LOT OF RESISTANCE AND HAD TO BE WITHDRAWN. THE DEVICES WERE REPLACED WITH LARGER SIZES. GIANT ANEURYSM WAS NOTED AS AN INCIDENTAL FINDING. THE PATIENT WAS TREATED SUCCESSFULLY WITH THE DEVICES, BUT EXPERIENCED A PERFORATOR STROKE 24 HOURS POST PROCEDURE, FOLLOWED BY A HEMORRHAGE AND DEATH. THE DEVICES WERE PREPARED PER THE IFU. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR LEFT MCA ANEURYSM WITH A MAX DIAMETER OF 15MM AND A NECK DIAMETER OF 8MM. ANCILLARY DEVICES INCLUDE A BENCHMARK GUIDE CATHETER, PHENOM 27 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: Death; Intracranial Hemorrhage

  MAUDE report 10530946 ↗
• MalfunctionSep 2, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE SEPARATED DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 7.88MM AND A 3.55MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, BUT THE SPECIFIC PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT DURING DELIVERY OF THE PIPELINE, THE STENT'S TIP OPENED WELL, THE PHYSICIAN PULLED BACK FOR POSITIONING, AND EVERYTHING WENT SMOOTHLY. HOWEVER, IN THE PROCESS OF CONTINUING DEPLOYMENT OF THE STENT, IT WAS FOUND THAT THE PUSHING ROD WAS PUSHED TO THE DISTAL SIDE, BUT THE STENT WAS NOT DEPLOYED. THE SURGEON TRIED TO RETRIEVE AND FOUND THERE WAS NO WAY TO RETRIEVE THE STENT. IT WAS THOUGHT THE PUSHWIRE MIGHT HAVE SEPARATED. THE STENT WAS THEN WITHDRAWN CAREFULLY TOGETHER WITH THE MARKSMAN MICROCATHETER. IT WAS STATED THERE WAS FRICTION/DIFFICULTY WITH BOTH THE PUSHING AND WITHDRAWAL PROCESS, BUT CLARIFIED THE STATEMENT WAS REFERRING TO THE STENT'S NON-RESPONSE TO THE PUSHWIRE. A NEW MARKSMAN AND PIPELINE WERE THEN USED, AND THE PROCEDURE WAS COMPLETED S

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

  MAUDE report 10483721 ↗
• InjuryMay 19, 2020Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE TIP BROKE AFTER PIPELINE FLEX BRAID IMPLANTED. TWO PIPELINES WERE SUCCESSFULLY DEPLOYED BUT BLEEDING DID NOT STOP SO INTERNAL CAROTID ARTERY (ICA) WAS SACRIFICED. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR BLEEDING OF A TUMOR RUPTURED DURING REMOVAL LOCATED IN ICA. THE VESSEL WAS OBSERVED MODERATELY TORTUOUS. IT WAS REPORTED THAT LONGER DEVICE THAT DID NOT DEPLOY PERFECTLY AND REQUIRED MANIPULATION TO DEPLOY. DURING THE FINAL STAGES OF DEPLOYMENT AND RETRIEVAL OF DEPLOYMENT SYSTEM, THE PIPELINE FLEX PUSHWIRE TIP BROKE OFF FROM DEVICE AND WAS LEFT FLOATING IN ICA AT THE PROXIMAL END OF THE DEPLOYED PIPELINE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ASPIRATE THE TIP OUT VIA THE DISTAL ACCESS SUPPORT CATHETER. THE PHYSICIAN STILL DEPLOYED THE PIPELINE WITH SUCCESS, REMOVED BROKEN TIP, AND WAS ABLE TO SUCCESSFULLY DEPLOY A SECOND PIPELINE FOR ADDITIONAL FLOW REDUCTION AT INJURY SITE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10071439 ↗
• MalfunctionMar 16, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX DISTAL TIP OF THE DELIVERY SYSTEM SEPARATED. THE DEVICE SEPARATION OCCURRED AFTER DEPLOYMENT OF THE DEVICE AND DURING RECAPTURE OF THE DELIVERY WIRE. THE SEPARATION OCCURRED WITHIN THE CATHETER. THE DEVICE TIP AND THE DEVILRY SYSTEM WILL BE RETURNED FOR ANALYSIS. THERE WAS NO PATIENT IMPACT AS A RESULT OF THIS EVENT. THE VESSEL ANATOMY WAS MODERATE. THIS EVENT OCCURRED IN THE LEFT VERTEBRAL. A CONTINUOUS FLUSHED WAS USED DURING THE CASE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). RESISTANCE WAS FELT WHEN THE DELIVERY WIRE WAS RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836907 ↗
• MalfunctionDec 11, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX DEVICE' PUSHWIRE BROKE. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A UNRUPTURED AMORPHOUS SUPRACLINOID INTERNAL CAROTID ARTERY (ICA), MEASURING 6MMX4MM, LANDING ZONE DISTAL 3.5MM PROXIMAL 3.7MM. THE VESSEL WAS OBSERVED NORMAL TORTUOUS. IT WAS REPORTED THAT CATHETER WAS FLUSHED AND PREPARED AS PER INSTRUCTIONS FOR USE (IFU). IT WAS DELIVERED TO THE DESIRED LOCATION WITHOUT ANY TROUBLE. PED-400-20 (PED) WAS ADVANCED INTO THE MICROCATHETER. IT WAS PUSHED WELL WITHOUT ANY RESISTANCE, IT WAS THEN ATTEMPTED TO BE DEPLOYING BUT THE OPERATOR WAS NOT HAPPY WITH THE OPENING HENCE TRIED TO RESHEATHED IT WITH THE MICROCATHETER. RESISTANCE WAS FELT AND ALL OF A SUDDEN PIPELINE PUSHER WIRE WAS MOVING FREELY INTO THE CATHETER. THE COMPLETE SYSTEM WAS TAKEN OUT TO INSPECT. IT WAS FOUND THAT THE DISTAL PORTION OF PED WAS BROKEN AND THE CATHETER DISTAL PART WAS STRETCHED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. PRU LEVEL WAS 157. THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. THE POST PROCEDURE ANGIOGRAPHY RESULTS SHOW SUCCESSFUL DEPLOYMENT OF ANOTHER PED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9450654 ↗
• MalfunctionNov 18, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WAS ADVANCED INTO THE INTENDED LOCATION, HOWEVER, THE PIPELINE WAS UNABLE TO OPEN AT THE DISTAL SECTION. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS USED. THE PIPELINE WAS LESS THAN 50% DEPLOYED WHEN IT FAILED TO OPEN. THE DEVICE WAS RESHEATHED LESS THAN 2 TIMES. THE ANATOMY WAS MODERATE. NO PATIENT INJURY OCCURRED. THERE WAS NO DAMAGE NOTICED TO THE DEVICES. THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED, SACCULAR, ANEURYSM. THE MAX DIAMETER WAS 6.5X 54MM AND THE NECK WAS 6MM. THE DISTAL LANDING ZONE WAS 3.98MM AND THE PROXIMAL WAS 3.84MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9336301 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  MEDTRONIC RECEIVED REPORT THAT POST THE UNEVENTFUL PIPELINE EMBOLIZATION PROCEDURE, THE PIPELINE THROMBOSED FROM THE DISTAL TO THE PROXIMAL END. IT WAS REPORTED THAT EFFIENT (PRASUGREL) WAS ADMINISTERED BEFORE THE INTERVENTION, THE OPTIMO 9FR WAS PLACED IN THE LEFT INTERNAL CAROTID ARTERY AND INTRODUCED TO THE PROXIMAL OF THE THROMBUS PART AT PENANBRA ACE 68, MARKSMAN AND CHIKAI 14, MARKSMAN WAS PLACED AT THE DISTAL PART OF THE THROMBUS. AFTERWARDS, A SOLITAIRE 6 MM × 40 MM WAS DELIVERED AND RETRIEVED. THROMBUS MATERIAL WAS COLLECTED, BUT THROMBUS FORMED AGAIN, SO ANOTHER PASS WAS MADE WITH THE SOLITAIRE, AND AGAIN THROMBUS WAS REMOVED. FOR FEAR THAT THROMBUS WOULD FORM AGAIN, A LVIS 4.5 MM × 23 WAS PLACED TO OVERLAP WITH THE PREVIOUSLY PLACED PIPELINE, AND PTA WAS PERFORMED FOR STENT CRIMPING AT SHOURYU 7 × 7. AFTER WAITING, THE BLOOD FLOW IN THE BRAIN RECOVERED AND THE THROMBUS DID NOT NEWLY INCREASE, SO THE PROCEDURE WAS TERMINATED. THE ANATOMY WAS REPORTED TO HAVE BEEN MODERATE IN TORTUOSITY. IT WAS REPORTED THAT THE PATIENT WAS ASYMPTOMATIC POST THE INTERVENTION. THE ANEURYSM WAS REPORTED TO HAVE BEEN 14 MM AND THE VESSEL DIAMETER WAS SMALL. ANCILLARY DEVICES: OPTIMO9F, PENANB

  Patient problems: Thrombosis

  MAUDE report 8405065 ↗

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-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-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