TrevoRecalls & reported problems across all models

We found 7 models of Trevo by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 84 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Nov 21, 2025 — classified as 3 deaths, 59 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (14 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Trevo recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1904-2024 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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-1902-2024 · Root cause: Process design · names 4 of these models · Recall details · FDA record ↗

4. Dec 6, 2023Open, Classified

   The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

   Z-1084-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Trevo problems

Trevo models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Trevo 90238

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  2 recalls5 reports
• Trevo 90183

  CATHETER, THROMBUS RETRIEVER
  1 recall1 death30 reports
• Trevo 90182

  CATHETER, THROMBUS RETRIEVER
  1 recall1 death29 reports
• Trevo 90184

  CATHETER, THROMBUS RETRIEVER
  1 recall1 death13 reports
• Trevo 90231

  CATHETER, PERCUTANEOUS
  1 recall4 reports
• Trevo 80052
  1 recall2 reports
• Trevo 80051
  1 recall1 report

Recent Trevo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING AN INTRACRANIAL MIDDLE CAROTID ARTERY (MCA) THROMBECTOMY PROCEDURE, THE OPERATOR PREPARED TO USE THE SUBJECT STENT RETRIEVER FOR THROMBECTOMY. AFTER DELIVERING THE MICROCATHETER TO THE TARGET SITE, THE OPERATOR STARTED TO ADVANCE THE SUBJECT STENT RETRIEVER. HOWEVER, IT ENCOUNTERED RESISTANCE UPON ENTERING THE MICROCATHETER, AND THE RESISTANCE INCREASED AS THE SUBJECT STENT RETRIEVER ADVANCED FURTHER. THE SUBJECT STENT RETRIEVER WAS DELIVERED TO THE TARGET LESION AND DEPLOYED. AFTER WAITING FOR APPROXIMATELY 5 MINUTES, THE OPERATOR ATTEMPTED TO RETRACT THE SUBJECT STENT RETRIEVER, BUT IT COULD NOT BE PULLED BACK AND BECAME STUCK IN THE VESSEL. THUS, THE OPERATOR ADVANCED THE ASPIRATION CATHETER PAST HALF OF THE STENT RETRIEVER AND WAS ABLE TO RETRACT IT INTO THE CATHETER EXPERIENCING SIGNIFICANT RESISTANCE. THE SUBJECT DEVICE WAS REPLACED, AND 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 23621921 ↗
• MalfunctionMar 24, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SUBJECT STENT RETRIEVER WAS PULLED OUT AFTER ONE PULL, PHYSICIAN SAW THAT THERE WAS A LOOSE THREAD AT THE END OF THE SUBJECT STENT RETRIEVER. IT MAY APPEAR THAT PARTS OF THE SUBJECT STENT RETRIEVER HAVE COME LOOSE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. UPDATE: THE SUBJECT STENT RETRIEVER WAS RETURNED FOR ANALYSIS AND WAS EXAMINED, AND IT WAS DISCOVERED THAT THE REPORTED EVENT OF THE SUBJECT STENT RETRIEVER BEING BROKEN/FRACTURE DURING USE WAS NOT CONFIRMED. THE SUBJECT RETRIEVER INSERTION TOOL WAS NOTED TO BE KINKED/BENT, COILS WERE DAMAGED, AND A FOREIGN MATERIAL WAS NOTED WRAPPED AROUND THE DISTAL END OF THE RETRIEVER SHAPED SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678659 ↗
• MalfunctionAug 14, 2024Peeled/Delaminated; Peeled/Delaminated

  DURING RIGHT INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY PROCEDURE, THE OPERATOR FLUSHED AND DELIVERED A GUIDEWIRE INTO A SUBJECT MICROCATHETER AND DELIVERED THEM TO THE TARGET LESION. AFTER THE SUBJECT MICROCATHETER REACHED MCA M1, THE OPERATOR DEPLOYED A RETRIEVER AND ASPIRATED WITH A DISTAL ACCESS CATHETER AT SIPHON SECTION. NEXT, THE OPERATOR WITHDREW THE RETRIEVER AND THE SUBJECT MICROCATHETER BACK INTO THE DISTAL ACCESS CATHETER AND CHECKED ICA C7 UNDER THE DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). THE ANGIOGRAPHY REVEALED THAT THE C7 WAS NOT OPENED. THE OPERATOR PREPARED TO PERFORM THE SECOND THROMBECTOMY. WHEN THE OPERATOR DELIVERED THE GUIDEWIRE INTO THE SUBJECT MICROCATHETER, HE FELT FRICTION AND RESISTANCE. WHEN THE OPERATOR REACHED M1, HE DELIVERED THE RETRIEVER AND IT ALSO ENCOUNTERED RESISTANCE INSIDE THE SUBJECT MICROCATHETER. THUS, THE OPERATOR WITHDREW THE RETRIEVER AND THE DISTAL ACCESS CATHETER AND REPLACED THE SUBJECT MICROCATHETER. THE OPERATOR CONCLUDED THAT THE COATING OF THE SUBJECT MICROCATHETER PEELED OFF WHICH CAUSED THE RESISTANCE. 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 19986746 ↗
• MalfunctionMar 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE WHEN THE OPERATOR ATTEMPTED TO DELIVER THE RETRIEVER STENT THROUGH THE SUBJECT MICROCATHETER, THE STENT RETRIEVER COULD NOT BE ADVANCED PAST MIDDLE CEREBRAL ARTERY (MCA) C5 SEGMENT. THE OPERATOR WITHDREW THE SUBJECT MICROCATHETER AND THE STENT OUT TOGETHER TO CHECK AND FOUND THAT THE INNER WALL PTFE LINER OF THE SUBJECT MICROCATHETER WAS PEELED. THE SUBJECT MICROCATHETER WAS REPLACED AND 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 18984012 ↗
• 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 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE ON (B)(6) 2020, THE PATIENT SUFFERED FROM HEMORRHAGIC TRANSFORMATION-BLOOD BRAIN BARRIER RUPTURE. IT WAS REPORTED THERE WAS A POSSIBLE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND SUBJECT RETRIEVER DEVICE USED IN THE PROCEDURE. IT WAS REPORTED THE STROKE (DISEASE UNDER STUDY) AND THE THROMBECTOMY PROCEDURE WERE RELATED TO THE ADVERSE EVENT. THE EVENT RESOLVED WITH UNKNOWN CLINICAL SEQUALAE ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446220 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED SPASM WHICH WAS TREATED WITH THE MEDICATION. IT IS NOTED THAT THE ADVERSE EVENT (SPASM) HAS POSSIBLY RELATIONSHIP TO THE THROMBECTOMY PROCEDURE AND THE SUBJECT STUDY DEVICE RETRIEVER, NOT RELATED TO STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED WITHOUT CLINICAL SEQUALAE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17080602 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE ON (B)(6) 2020, THE PATIENT EXPERIENCED HEMORRHAGE AS IDENTIFIED AS PARENCHYMATOUS HEMATOMA 2. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT CATALYST DEVICE. NO FURTHER INFORMATION IS AVAILABLE. UDATED: FURTHER REVIEWING FROM MEDICAL SAFETY TEAM INDICATED THAT THE PATIENT EXPERIENCED SUB ARACHNOID HEMORRHAGE (SAH) AT THE LEFT SYLVIAN. ADDITIONALLY, THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE AS THE EVENT HAD NO RELATION TO THE CATALYST DEVICE AS PREVIOUSLY REPORTED. THIS REPORT REFERS TO THE SUBJECT STUDY RETRIEVER DEVICE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage

  MAUDE report 17078152 ↗
• DeathJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE FIRST TREATMENT STRATEGY FROM A THROMBECTOMY PROCEDURE ON (B)(6) 2021, THE PATIENT SUFFERED VESSEL PERFORATION /RUPTURE ON STENOSED ARTERY AND HIV WHICH WERE TREATED WITH THE MEDICATION AND SUBSEQUENTLY THERE WAS PATIENT DEATH. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE, THROMBECTOMY PROCEDURE, DISEASE UNDER STUDY AND TO AN UNDERLYING CONDITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels; Viral Infection

  MAUDE report 17052823 ↗
• 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 ↗
• MalfunctionNov 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACUTE THROMBECTOMY CASE, WHEN THE PHYSICIAN ATTEMPTED TO BUILD ACCESS WITH THE SUPPORT OF A GUIDEWIRE, THE DISTAL OF THE SUBJECT CATHETER KINKED AND EVENTUALLY FRACTURED WHILE BEING DELIVERED INTO THE PATIENT. THE DEVICE WAS REMOVED WITH THE GUIDEWIRE AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886476 ↗
• 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 ↗
• MalfunctionDec 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT CATHETER WAS BROKEN DURING THE MEDICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13065412 ↗

Other Stryker Corporation products

• RemB7 models · 3,073 reports
• Prime Series21 models · 1,548 reports · 2 recalls
• TARGET114 models · 1,077 reports
• ProCuity17 models · 368 reports · 13 recalls
• Spetzler-Malis20 models · 7 reports · 19 recalls
• SYNCHRO 28 models · 313 reports · 9 recalls
• Neptune E-SEP19 models · 412 reports · 7 recalls
• StrykeFlow4 models · 552 reports · 4 recalls