Trevo XPRecalls & reported problems across all models

We found 2 models of Trevo XP by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2017 and Jan 16, 2024 — classified as 2 deaths, 55 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 reports).

1 FDA recall record name at least one of these models by its device 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. 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 XP 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-1902-2024 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Trevo XP problems

Trevo XP models

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

• Trevo XP 90185

  CATHETER, THROMBUS RETRIEVER
  1 recall1 death40 reports
• Trevo XP 90186

  CATHETER, THROMBUS RETRIEVER
  1 recall1 death31 reports

Recent Trevo XP adverse event reports

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

• MalfunctionJan 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS USED FOR ACUTE AIS (ACUTE ISCHEMIC STROKE) PROCEDURE, AS THE CTA (COMPUTED TOMOGRAPHY ANGIOGRAPHY) SHOWED A LONG OCCLUSION AT THE LEFT MCA (MIDDLE CEREBRAL ARTERY). THE OPERATOR-BUILT ACCESS AND THEN USED THE SUBJECT STENT RETRIEVER TO PERFORM A THROMBECTOMY. AFTER THE FIRST ATTEMPT, THE VESSEL WAS NOT COMPLETELY CLEAR, THEREFORE; THE SECOND ATTEMPT WAS MADE, THE BIG RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT STENT RETRIEVER INTO THE RETRIEVER MICROCATHETER. THE SUBJECT STENT RETRIEVER WAS REMOVED FROM THE PATIENT'S ANATOMY AND FOUND THE DISTAL OF THE SUBJECT STENT RETRIEVER PLATINUM COIL WAS DAMAGED. THE OPERATOR REPLACED IT WITH THE CATALYST CATHETER FOR ASPIRATION AND FINISHED THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519686 ↗
• 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 17447286 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE THROMBECTOMY PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL HEMORRHAGE. IT IS NOTED THAT THE ADVERSE EVENT HAS POSSIBLY RELATIONSHIP TO THE SUBJECT STUDY RETRIEVER DEVICE, STROKE (DISEASE UNDER STUDY), UNDERLYING CONDITION, AND THROMBECTOMY PROCEDURE. THE PATIENT PROLONGED HOSPITALIZATION. NO ACTION WAS TAKEN, AND THE EVENT RESOLVED WITH CLINICAL "SEQUELAE". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17132006 ↗
• 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 STUDY RETRIEVER DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17078367 ↗
• InjuryJun 6, 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) 2020, 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 RETRIEVER DEVICE, NOT RELATED TO THE STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION OR DISEASE. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2020 WITHOUT CLINICAL SEQUALAE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17071434 ↗
• InjuryJun 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 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 THE STROKE (DISEASE UNDER STUDY) AND TO AN UNDERLYING CONDITION OR DISEASE. THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2021 WITHOUT CLINICAL "SEQUELAE". NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vasoconstriction

  MAUDE report 17054044 ↗
• MalfunctionNov 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS ADVANCED THROUGH THE MICROCATHETER AND WHEN THE PHYSICIAN TRIED TO RETURN THE PUSHERWIRE, THE SUBJECT STENT RETRIEVER BROKE. THERE WAS A SURGICAL DELAY OF UNKNOWN DURATION DUE TO THE EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890985 ↗
• InjuryMay 19, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT THE SUBJECT SENT DEVICE (TREVO XP) WAS USED ON ONE RIGHT MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM CASE. PUNCTURED THROUGH RIGHT FEMORAL ARTERY AND PLACED 8F CODIS GUIDE CATHETER, SOFIA ASPIRATION CATHETER, PRO-18 MICROCATHETER AND SYNCHRO GUIDEWIRE TO BUILD ACCESS AND PLACED MIDDLE CATHETER AND MICROCATHETER TO THE LOCATION. PREPARED TO USE A SUBJECT DEVICE SYENT. CHECKED IT AND FLUSHED IT NORMALLY AND THEN DELIVERED IT INTO PRO18 MICROCATHETER. AFTER IT WAS PLACED TO THE LOCATION, DEPLOYED IT AND WITHDREW IT NORMALLY. FOR THE FIRST TIME TO WITHDRAW, NO THROMBUS WAS OBSERVED. SO THE OPERATOR DELIVERED IT TO DEPLOY AGAIN AND WHEN WITHDRAWING THE SUBJECT STENT, BIG RESISTANCE WAS ENCOUNTERED AND THE SUBJECT STENT COULD NOT BE RETRACTED. TRIED SEVERAL TIMES THE SUBJECT STENT WAS SEPARATED AND LEFT IT IN THE VESSEL AND COULD NOT BE TAKEN OUT WITH A SNARE. THE OPERATOR COMMUNICATED WITH THE PATIENT AND FINALLY WITHDREW THE REST OF THE DEVICES AND FINISHED THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14438248 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN THE PROXIMAL LEFT M1, VESSEL PERFORATION OCCURRED WITH POSSIBLE RELATION TO THE STENT RETRIEVER (SUBJECT DEVICE). THE PHYSICIAN HAD PERFORMED 2 PASSES WITH THE SUBJECT STENT RETRIEVER WHEN THE EVENT OCCURRED. VESSEL DISSECTION AND DEVICE MALFUNCTION WERE NOT REPORTED DURING THE PROCEDURE. PHYSICIAN IS REPORTED TO HAVE COMPLETED THE PROCEDURE SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Perforation

  MAUDE report 11573033 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A THROMBECTOMY FOR LEFT DISTAL INFARCTION WAS PERFORMED USING THE SUBJECT STENT RETRIEVER. FIRST PASS WAS PERFORMED WITH THE SUBJECT STENT RETRIEVER AND ASPIRATION CATHETER. THE MODIFIED TREATMENT IN CEREBRAL INFARCTION (MTICI) SCORE IMPROVED TO 3 AFTER FIRST PASS. THERE WAS NO REPORTED PATIENT INJURY SUCH AS VESSEL PERFORATION AND VESSEL DISSECTION. NO DEVICE MALFUNCTION WAS REPORTED DURING PROCEDURE. IMAGING FOLLOW-UP DONE THE NEXT DAY, 25.5 HOURS AFTER THE PROCEDURE REVEALED SUB ARACHNOID HEMORRHAGE (SAH). PATIENT CONDITION AND MEDICAL INTERVENTION DONE DUE TO THE EVENT IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11159019 ↗
• InjuryDec 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, FIRST PASS AND SECOND PASS WERE PERFORMED WITH THE SUBJECT STENT RETRIEVER AND AN ASPIRATION CATHETER. DIFFICULTY WAS ENCOUNTERED DEPLOYING THE SUBJECT STENT RETRIEVER AND THE PHYSICIAN WAS UNABLE TO DEPLOY IT. THEREFORE THE SUBJECT STENT RETRIEVER WAS REMOVED AND PHYSICIAN USED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO COMPLETE THE PROCEDURE AND ACHIEVE REPERFUSION. NO PATIENT INJURY, VESSEL PERFORATION OR VESSEL DISSECTION WAS REPORTED DURING THE PROCEDURE. TWENTY HOURS POST PROCEDURE, FOLLOW UP IMAGING REVEALED INTRACRANIAL HEMORRHAGE. TWENTY FIVE DAYS POST PROCEDURE, THE PATIENT'S CONDITION DETERIORATED DUE TO UNKNOWN CIRCUMSTANCES AND CURRENT CONDITION IS UNKNOWN. NO OTHER INFORMATION IS AVAILABLE

  Patient problems: Intracranial Hemorrhage

  MAUDE report 11074484 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBECTOMY PROCEDURE WAS PERFORMED USING THE SUBJECT RETRIEVAL DEVICE TO REMOVE A CLOT IN RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM AT M2 SEGMENT. PRIOR PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) OF 0, NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 7 AND MRS (MODIFIED RANKIN SCORE) OF 0. IT WAS REPORTED THAT DURING STUDY PROCEDURE, INTRACRANIAL HEMORRHAGE NEW SAH (SUBARACHNOID HEMORRHAGE) OCCURRED WITHIN THE RIGHT SYLVIAN FISSURE, NEW 1.2CM INTRAPARENCHYMAL HEMORRHAGE PROBABLY DUE TO IATROGENIC INJURY TO VESSEL. THE PROCEDURE WAS COMPLETED WITH THE FIRST PASS AND AFTER 24 HOURS POST PROCEDURE, THE PATIENT HAD (NIHSS) OF 2. THE EVENT WAS NOT SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) AND IT WAS RESOLVED WITHOUT MEDICAL TREATMENT TO THE PATIENT. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS OF 0 AND MRS OF 1 AND ON DAY 30 WITH MRS OF 1.

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

  MAUDE report 10997330 ↗
• InjuryDec 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER WAS USED DURING TWO TO THREE THROMBECTOMY ATTEMPTS. PHYSICIAN IS REPORTED TO HAVE APPLIED A SIGNIFICANT AMOUNT OF FORCE TO THE PROXIMAL END OF THE SUBJECT RETRIEVER, WHEN A FRACTURE OCCURRED. THE FRACTURE WAS NOTED AT THE PROXIMAL PART OF THE SUBJECT STENT RETRIEVER, WHEN UNSHEATHING FROM THE MICRO CATHETER WHILE INSIDE THE TARGET VESSEL. PHYSICIAN TRIED TO REMOVE THE BROKEN FRAGMENT OF THE SUBJECT STENT RETRIEVER WITH ANOTHER STENT BUT WAS UNSUCCESSFUL. THE CLOT IS REPORTED TO HAVE BEEN PARTIALLY REMOVED THROUGH ASPIRATION. PATIENT WAS GIVEN UNKNOWN ADDITIONAL MEDICATION DUE TO THIS EVENT. PATIENT CONDITION IS A LITTLE BETTER POST PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10932279 ↗
• MalfunctionNov 30, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT STENT RETRIEVER WAS DEPLOYED IN THE TARGET VESSEL AND STRONG RESISTANCE WAS ENCOUNTERED WHILE PULLING INTO THE MICRO CATHETER LUMEN. THE SUBJECT RETRIEVER WAS UNABLE TO BE PULLED INTO THE MICRO CATHETER LUMEN AND THEREFORE, BOTH DEVICES WERE SUCCESSFULLY AND COMPLETELY REMOVED FROM THE PATIENT'S ANATOMY. ON REMOVAL OF THE SUBJECT RETRIEVER, CLOTS WERE CONFIRMED AT THE TIP. POST OPERATIVE IMAGING SHOWED IMPROVED PERFUSION WITH THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924494 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THROMBECTOMY FOR RIGHT CERVICAL- ICA (INTERNAL CAROTID ARTERY) WAS PERFORMED ON PATIENT WITH MODIFIED RANKING SCALE: MRS SCORE: 3 (SCALE +3: MODERATE DISABILITY; REQUIRING SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE) AND ALBERTA STROKE PROGRAM EARLY CT SCORE: ASPECTS BEFORE PROCEDURE WAS (B)(6) 2020. FIRST PASS AND SECOND PASS WERE PERFORMED WITH RETRIEVER (SUBJECT DEVICE) AND ASPIRATION CATHETER. HOWEVER, THROMBOLYSIS IN CEREBRAL INFARCTION SCALE: TICI WAS STILL 0: NO PERFUSION AFTER 2 PASS. IN ADDITION, VESSEL DISSECTION OCCURRED DURING PROCEDURE, WHICH WAS ALLEGEDLY RELATED TO RETRIEVER. THERE WERE NO VESSEL PERFORATION, OR DEVICE MALFUNCTION DURING PROCEDURE. MRI FOLLOW-UP 12.5 HOURS AFTER THE PROCEDURE ON (B)(6) 2020 REVEALED ICH (INTRACRANIAL HEMORRHAGE). MODIFIED RANKING SCALE: MRS SCORE BECAME WORSE TO +4 (MODERATELY SEVERE DISABILITY; UNABLE TO WALK AND ATTEND TO BODILY NEEDS WITHOUT ASSISTANCE) THOUGH NATIONAL INSTITUTES OF HEALTH STROKE SCALE: NIHSS WAS CHANGED FROM 14 TO 13 ON OCT 26TH, 2020. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND IT IS UNDER CONFIRMATION WHY THE PROCEDURE WAS FINISHED THOUGH TICI WAS 0 AFTER 2ND

  Patient problems: Intracranial Hemorrhage; Vascular Dissection

  MAUDE report 10893175 ↗

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