Trevo 90184Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00815742001846), received between Oct 18, 2018 and Dec 13, 2023 — classified as 1 death, 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1903-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING ICA (INTERNAL CAROTID ARTERY) OCCLUSION PROCEDURE, THE OPERATOR PLACED GUIDING CATHETER AND DISTAL ACCESS CATHETER TO MAKE BASIC ACCESS AND USED DISTAL ACCESS CATHETER TO DO ASPIRATION FROM C2 BEGINNING. MASSIVE THROMBUS WAS TAKEN OUT. WHEN REACHED C7, THIS SEGMENT WAS NOT ABLE TO BE ASPIRATED CLEARLY SO THE OPERATOR USED A GUIDEWIRE TO BRING MICROCATHETER TO PASS THE OCCLUSION TO REACH MCA (MIDDLE CEREBRAL ARTERY) M1 DISTAL AND THEN DELIVERED THE RETRIEVER (SUBJECT DEVICE). AFTER DEPLOYING THE RETRIEVER (SUBJECT DEVICE) AND WAITED FOR 5 MIN, THE OPERATOR ADVANCED THE DISTAL ACCESS CATHETER TO PROXIMAL OF OCCLUSION TO ASPIRATE AND BEGAN TO USE RETRIEVER (SUBJECT DEVICE) TO TAKE THE THROMBUS OUT. THE OPERATOR WITHDREW THE RETRIEVER (SUBJECT DEVICE) INTO DISTAL ACCESS CATHETER AND AFTER IT WAS COMPLETELY PULLED INTO DISTAL ACCESS CATHETER IT GOT STUCK AND COULD NOT BE PULLED ANY MORE. THE OPERATOR CONTINUED TO DO ASPIRATION AND THEN WITHDREW THE DISTAL ACCESS CATHETER, RETRIEVER (SUBJECT DEVICE), AND MICROCATHETER AS A WHOLE SYSTEM OUT OF PATIENT'S BODY. HOWEVER, THE OPERATOR FOUND ONLY DELIVERY WIRE WAS TAKEN OUT AND THE STENT WAS NOT TAKEN OUT. HE THOUGH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319041 ↗
• MalfunctionApr 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE RIGHT ICA C6 ACUTE OCCLUSION PROCEDURE, PHYSICIAN DELIVERED INTERMEDIATE CATHETER TO C4 AND REACHED C6 UNDER ASPIRATION. PHYSICIAN USED THE ADAPT TECHNIQUE TO ASPIRATE THE THROMBUS, BUT THE ICA WAS STILL OCCLUDED. USING GUIDEWIRE, THE MICROCATHETER WAS BROUGHT TO RIGHT MCA M2 AND THEN DEPLOYED THE SUBJECT STENT RETRIEVER. THE PHYSICIAN USED THE SOLUMBRA TECHNIQUE AND RETRACTED THE SUBJECT STENT RETRIEVER AT THE SAME TIME. HOWEVER, RESISTANCE WAS FELT WHEN THE SUBJECT STENT RETRIEVER WENT INTO THE TIP OF THE INTERMEDIATE CATHETER. THE PHYSICIAN PULLED THE SUBJECT STENT OUT FROM TAIL OF INTERMEDIATE CATHETER AND FOUND THAT THE CONNECTION BETWEEN STENT AND DELIVERY WIRE WAS FRACTURED. TOOK THE STENT OUT AND CONFIRMED THAT MUCH THROMBUS WAS TAKEN OUT. THEN CONTINUED TO USE INTERMEDIATE CATHETER TO ASPIRATE BUT MIDDLE OF M1 TO DISTAL WAS STILL OCCLUDED. THEN USED A GUIDEWIRE AND MICROCATHETER TO BRING INTERMEDIATE CATHETER TO M1 TO ASPIRATE WITH ADAPT TECHNIQUE. FINALLY, THE VESSEL WAS CLEAR AND CONFIRMED TICI 3. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16687412 ↗
• MalfunctionMar 9, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING ONE LEFT MCA (MIDDLE CEREBRAL ARTERY) ACUTE OCCLUSION PROCEDURE, WHEN DELIVERING THE GUIDER TO THE LEFT ICA (INTERNAL CAROTID ARTERY) C1 TAIL, THEN DELIVERED CATALYST UNDER THE GUIDING OF MICROCATHETER AND SYNCHRO GUIDEWIRE TO ICAC7. FLUSHED AND DELIVERED A SUBJECT RETRIEVER BUT RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT RETRIEVER IN MICROCATHETER. TRIED TO DELIVER IT TO THE THROMBUS AND THEN WITHDREW THE MICROCATHETER TO DEPLOY THE SUBJECT RETRIEVER, AND AFTER WAITING FOR 5 MINUTES, THE SUBJECT RETRIEVER WAS NOT EXPANDED AS EXPECTED. THE SUBJECT RETRIEVER WAS WITHDRAWN, AND IT WAS FOUND TO BE DEFORMED. THE SUBJECT RETRIEVER WAS REPLACED WITH ANOTHER NEW RETRIEVER TO CONTINUE THE PROCEDURE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518777 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) M1 BIFURATION THROMBUS CASE, DELIVERED GUIDING CATHETER TO C2 AND THEN USED GUIDEWIRE TO BRING PR-18 CATHETER TO PASS THE THROMBUS TO M2 SEGMENT AND DELIVERED CAT6 GUIDING CATHETER TO M1 TO NEAR THE THROMBUS. DURING DELIVERY OF THE STENT THE OPERATOR FELT RESISTANCE INSIDE THE CATHETER, WITHDREW THE STENT AND FOUND THE INSERTION TOOL DAMAGED, SO REPLACED IT WITH ANOTHER STENT TO DO THROMBECTOMY. AFTER THIS STENT (SUBJECT DEVICE) WAS DEPLOYED TO CATCH THE THROMBUS AND RETRACTED OUT, THE VESSEL DEFORMED SEVERELY (THE SHAPE OF THE VESSEL CHANGED). SO THE OPERATOR PLACED THE CAT6 TO NEAR THE PROXIMAL OF STENT AND USED PR-18 TO TAKE THE STENT OUT AND USED CAT6 TO DO ASPIRATION SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15205326 ↗
• MalfunctionAug 3, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE BASILAR ARTERY ACUTE THROMBECTOMY CASE, RESISTANCE WAS FELT WHILE INSERTING THE SUBJECT RETRIEVER INTO THE MICROCATHETER HUB AND WITHIN THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO MOVE THE SUBJECT RETRIEVER WITH RESISTANCE AND COMPLETED THE FIRST THROMBECTOMY PASS. ON WITHDRAWING, RESISTANCE WAS FELT WHILE REMOVING THE SUBJECT RETRIEVER OUT OF THE PATIENT VESSEL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156610 ↗
• MalfunctionJan 21, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN ACUTE OCCLUSION CASE WHERE THERE WAS THROMBUS AT THE MIDDLE CEREBRAL ARTERY (MCA) THE STENT RETRIEVER (SUBJECT DEVICE) WAS STUCK AND COULD NOT BE PULLED BACK TO BE REMOVED FROM THE VESSEL. THE PHYSICIAN USED ALREADY IN USE MICROCATHETER TO WITHDRAW THE SUBJECT RETRIEVER INTO THE CATHETER AND REMOVE IT FROM THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208314 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBUS MIGRATION TO THE NEW TERRITORY OCCURRED DURING THE PROCEDURE. NO ADVERSE CONSEQUENCES WERE REPORTED DUE TO THIS EVENT.

  Patient problems: Thromboembolism

  MAUDE report 10783113 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE STUDY PROCEDURE, THE VESSEL PERFORATION LEADING TO SUBARACHNOID HEMORRHAGE INVOLVING THE RETRIEVER (SUBJECT DEVICE). THE OUTCOME OF THE EVENT WAS RESOLVED 2 DAYS POST PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. UPDATE INFORMATION: RECEIVED ADDITIONAL INFORMATION STATED THAT THE VESSEL PERFORATION LOCATED AT M2/M3 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) LEADING TO SUBARACHNOID HEMORRHAGE AND THE EVENT WAS RESOLVED. NEUROLOGICAL ASSESSMENT SHOWED PRE- PROCEDURE A NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) SCORE OF 18 AND 24 HOURS POST PROCEDURE NIHSS SCORE OF 6.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 9747145 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMBOLI IN NEW TERRITORY (ENT) WAS NOTICED DURING THE THROMBECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO TREATMENT WAS PROVIDE TO THE PATIENT FOR THE ENT AND NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: Embolus

  MAUDE report 9747082 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE, THE EMBOLI WAS OBSERVED WITHIN THE PREVIOUSLY UNAFFECTED TERRITORY. THEN THROMBECTOMY WAS ADMINISTRATED AS A TREATMENT TO REMOVE THE MIGRATED EMBOLI AND IT WAS RESOLVED. THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT DUE TO THE ENT (EMBOLIZATION IN NEW TERRITORY).

  Patient problems: Embolus

  MAUDE report 9470407 ↗
• DeathSep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED FOR UNKNOWN REASON AFTER THROMBECTOMY PROCEDURE AT THE RIGHT MCA (MIDDLE CAROTID ARTERY) M1. THE DEATH OCCURRED BETWEEN 34 TO 102 DAYS POST PROCEDURE. 7 DAYS POST-PROCEDURE, THE PATIENT¿S MRS (MODIFIED RANKIN SCALE) WAS 4 AND THE NIHSS (NATIONAL INSTITUTES OF HEALTH STROKE SCALE) WAS 10. IN ADDITION, 34 DAYS POST-PROCEDURE, THE PATIENT¿S MRS WAS 4 AS WELL. NO FURTHER INFORMATION IS PROVIDED FOR NOW.

  Patient problems: Death

  MAUDE report 9099828 ↗
• InjuryMay 16, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE TO TREAT THE OCCLUDED M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA), THE RETRIEVER(SUBJECT DEVICE) COULD NOT BE WITHDRAWN. FOLLOWING UNSUCCESSFUL ATTEMPT TO REMOVE THE CLOT WITH THE CONCOMITANT MICROCATHETER, THE PHYSICIAN ELECTED THE USE OF NON-STRYKER DEVICE TO ASPIRATE THE THROMBUS AND COMPLETED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8617791 ↗
• MalfunctionOct 18, 2018Break; Break

  ANALYSIS OF THE RETURNED RETRIEVER (SUBJECT DEVICE) REVEALED THAT THE PLATINUM WIRE HAD BROKEN. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981012 ↗