Trevo NXT 90315Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07613327299953), received between Oct 6, 2020 and Nov 17, 2025 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K192207, K200117, K203219, K210502, K223305); 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.

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.

• InjuryNov 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT STENT RETRIEVER DETACHED. A SNARE DEVICE WAS USED TO REMOVE IT FROM THE PATIENT'S ANATOMY, BUT UNSUCCESSFULLY. A SURGICAL DELAY OF UNKNOWN LENGTH WAS REPORTED DUE TO THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23574893 ↗
• InjurySep 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBECTOMY OF INTERNAL CAROTID ARTERY (ICA) OCCLUSION, A SECOND APPROACH WAS PERFORMED DUE TO RESIDUAL THROMBUS. THE STENT DEPLOYMENT PROCEEDED WITHOUT ISSUE, BUT DURING RETRIEVAL, DESPITE PULLING THE ENTIRE SYSTEM, THE SUBJECT STENT DELIVERY WIRE BECAME FRACTURED, LEAVING THE SUBJECT STENT AND PART OF THE WIRE IN THE BODY. SUBSEQUENTLY, ATTEMPTS WERE MADE TO RETRIEVE THE REMAINING DEVICES USING A STENT RETRIEVER AND SNARE DEVICE, BUT THESE PROVED UNSUCCESSFUL. THEREFORE, TREATMENT WAS CONCLUDED WITH THE DEVICES REMAINING INSIDE THE PATIENT'S BODY. THE PATIENT'S ADL WAS ALREADY POOR, AND THE IMPACT OF THIS EVENT IS UNCLEAR.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151656 ↗
• MalfunctionSep 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STENT RETRIEVER (SUBJECT DEVICE) WAS USED IN A THROMBUS RETRIEVAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT DEVICE WITHIN THE MICROCATHETER. AFTER THE THROMBUS WAS RETRIEVED THE DELIVERY WIRE OF THE SUBJECT DEVICE WAS OBSERVED TO BE FRACTURED, THE FRACTURED PART WAS WITHIN THE ASPIRATION CATHETER AND WAS RETRIEVED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23111218 ↗
• MalfunctionMar 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING LARGE VESSEL OCCLUSION LVO PROCEDURE, WHEN THE SUBJECT STENT RETRIEVER WAS RETRACTED, THE RETRIEVER BECAME DETACHED FROM THE WIRE. THERE WAS A SURGICAL DELAY OF 10MIN DUE TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21509450 ↗
• InjuryDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING ACUTE CEREBRAL INFARCTION AND OCCLUSION OF THE RIGHT MIDDLE CAROTID ARTERY (MCA) M1 PROCEDURE, THE OPERATOR DEPLOYED THE SUBJECT STENT RETRIEVER TO PINCH A THROMBUS. NEXT, THE SUBJECT STENT WAS CAREFULLY REMOVED DUE TO RESISTANCE FELT. HOWEVER, THE SHAPED SECTION AND THE DELIVERY WIRE GOT DISCONNECTED AND THE SHAPED SECTION REMAINED IN THE VESSEL. THE CONTRAST ANGIOGRAPHY WAS PERFORMED AND THE MCA WAS NOT VISUALIZED, INDICATING THAT THE VESSEL WAS COMPLETELY OCCLUDED. THE OPERATOR ATTEMPTED TO REMOVE THE SHAPED SECTION WITH ANOTHER STENT RETRIEVER BUT UNSUCCESSFULLY. NEXT, THE OPERATOR USED THE SNARE TO REMOVE THE SHAPED SECTION SUCCESSFULLY. IMMEDIATELY AFTER THIS, THE ANGIOGRAPHY WAS PERFORMED AND IT DID NOT REVEAL THE RIGHT M2 OR INFERIOR TRUNK, BUT IT WAS CONFIRMED THAT PARTIAL RECANALIZATION HAD BEEN ACHIEVED. CONTRAST-ENHANCED CONE-BEAM COMPUTED TOMOGRAPHY (CBCT) IMAGING WAS PERFORMED TO CONFIRM THAT THERE WAS NO OBVIOUS BLEEDING. INDOCYANINE (IC) ANGIOGRAPHY WAS PERFORMED AND A THROMBUS WAS FOUND IN THE CAROTID ARTERY SYPHON'S AREA, AND PERIPHERAL VISUALIZATION WAS ALSO DETERIORATED. VASCULAR DAMAGE DUE TO MULTIPLE DEVICE INDUCTIONS AND REMOVAL OF

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20873085 ↗
• InjuryMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE MIDDLE CEREBRAL ARTERY INFARCTION PROCEDURE, PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER AT THE PROXIMAL OF M1. WHILE ATTEMPTING TO WITHDRAWING THE SUBJECT STENT RETRIEVER TOGETHER WITH THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. THE SUBJECT STENT RETRIEVER WAS FRACTURED FROM THE DELIVERY WIRE. THE FRACTURED PART OF THE SUBJECT STENT RETRIEVER WAS LEFT WITHIN THE PATIENT ANATOMY. THE PHYSICIAN HAS THE OPINION THAT ONE OF THE REASONS WAS THAT THERE WAS SEVERE TORTUOSITY THAT THE VESSELS NEAR THE INTERNAL CAROTID ARTERY - TOP WERE TORTUOUS AND THE ASPIRATION CATHETER WAS NOT ABLE TO RAISE UP. THE PATIENT IS HOSPITALIZED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18989548 ↗
• InjuryFeb 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THIRD PASS OF THE THROMBECTOMY PROCEDURE, THERE WAS RESISTANCE WHILE USING THE SUBJECT STENT RETRIEVER WITH MICROCATHETER AND THE SUBJECT STENT RETRIEVER WAS BROKEN BETWEEN THE STENT AND THE DISTAL TIP OF THE DELIVERY WIRE AND THE STENT PART WAS LEFT IN THE PATIENT'S BLOOD VESSEL. THE DOCTOR JUDGED THAT THE STENT PART COULD NOT BE REMOVED, AND THE PROCEDURE WAS TERMINATED WHILE THE SUBJECT STENT RETRIEVER WAS LEFT IN THE BLOOD VESSEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18660594 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, THERE WAS DIFFICULTY TO ADVANCE THE SUBJECT STENT RETRIEVER INITIALLY AND THEN IT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. THERE WAS A SURGICAL DELAY OF 5-10 MINUTES DUE TO THE REPORTED ISSUE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17068362 ↗
• InjuryApr 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE FOR M1 CEREBRAL INFARCTION IN A PATIENT, THERE WAS RESISTANCE WHEN THE SUBJECT STENT RETRIEVER WAS WITHDRAWN FROM THE PATIENT ANATOMY AND THE SUBJECT STENT CORE WIRE BROKE OFF WHILE RETRIEVING THE THROMBUS WITH ASPIRATION CATHETER. THE BROKEN SUBJECT STENT WAS RETRIEVED WITH A SNARE. RECANALIZATION COULD NOT BE OBTAINED; THE PROCEDURE WAS COMPLETED AS IT WAS. ALTHOUGH THE INFARCTED NEST HAS SPREAD, IT WAS NOT CAUSED BY A PRODUCT DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815493 ↗
• InjuryFeb 13, 2023Fracture; Fracture

  IT WAS REPORTED DURING A THROMBUS REMOVAL PROCEDURE WHEN ATTEMPTING TO DEPLOY THE RETRIEVER (SUBJECT DEVICE) IT DETACHED FROM THE DELIVERY WIRE. A SNARE WAS USED TO REMOVE THE SUBJECT RETRIEVER FROM THE PATIENT. 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 16363358 ↗
• InjuryDec 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE, THE PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER AT THE INTERNAL CAROTID ARTERY. WHILE WITHDRAWING, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER WAS BROKEN INSIDE THE PATIENT ANATOMY. A SNARE STENT WAS USED TO RETRIEVE THE BROKEN PART. 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 16002832 ↗
• InjuryApr 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN AIS TREATMENT, THE SUBJECT RETRIEVER DETACHED FROM ITS DELIVERY WIRE UPON DEPLOYMENT. THE PHYSICIAN REMOVED THE FRAGMENT BY USING A SNARE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS VERY MEANDERING. 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 14009939 ↗
• InjuryMar 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT A COMBINATION MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED FOR NIHSS 18 IN A PATIENT WITH INTRA CRANIAL ATHEROSCLEROTIC DISEASE IN THE RIGHT MIDDLE CEREBRAL ARTERY WITH CALCIFIED CLOT. DURING THE FIRST PASS MILD RESISTANCE WAS FELT IN THE PROXIMAL SUPRACLINOID WHILE ADVANCING THE SUBJECT RETRIEVER STENT AND WHEN ATTEMPTED TO RETRIEVE THE SUBJECT RETRIEVER STENT CORE WIRE BROKE. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN SUBJECT RETRIEVER STENT USING A SNARE, BUT IT WAS NOT SUCCESSFUL AND THEREFORE THE SUBJECT RETRIEVER STENT WAS LEFT INSIDE THE PATIENT¿S VASCULAR ANATOMY (IN THE RIGHT MIDDLE CEREBRAL ARTERY). FOLLOW UP CT SCAN SHOWED SUBARACHNOID HEMORRHAGE WHICH WAS TREATED WITH MEDICAL MANAGEMENT. THE PROCEDURE COULD NOT BE COMPLETED, AND THE PATIENT WAS IN THE ICU (INTENSIVE CARE UNIT) ON A DAY WE RECEIVED THE INFORMATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13663681 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THROMBUS RETRIEVAL FOR AN ACUTE IC OCCLUSION TREATMENT, A GUIDE CATHETER AND A MICROCATHETER WERE USED TO DELIVER THE SUBJECT RETRIEVER TO THE TARGET SITE. THROMBUS WAS SUCCESSFULLY REMOVED; HOWEVER, OVER CONTRAST RUN IMMEDIATELY AFTER THE RETRIEVAL MASSIVE BLEEDING WAS OBSERVED IN THE IC. A MILD ATHEROSCLEROTIC LESION WAS CONSIDERED BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT¿S ANATOMY WAS NORMAL AND THERE WAS NO HEALTH DAMAGES AT THE PRESENT, BUT, THE PATIENT'S PROGNOSIS IS LIKELY TO BE POOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13654543 ↗
• MalfunctionSep 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE TREATMENT PROCEDURE, THE PHYSICIAN USED THE SUBJECT STENT TO COLLECT THE THROMBUS AT THE MIDDLE CEREBRAL ARTERY (MCA). THE TECHNOLOGIST PUSHED THE DEVICE OUT OF THE CATHETER AFTER THE FIRST PASS AND THE STENT WAS CLEANED AND PLACED UNDER THE TOWEL. THE TECHNOLOGIST DIDN'T NOTICE THE STENT WAS DETACHED FROM THE WIRE UNTIL LATER. THE PHYSICIAN DOESN¿T RECALL WHEN THE DETACHMENT OCCURRED. THE PHYSICIAN DID NOT ATTEMPT TO REUSE THE DEVICE ONCE THEY NOTICED THE FRACTURE OF THE STENT. THE PHYSICIAN ABORTED THE PROCEDURE, BUT NOT DUE TO THE STENT DETACHING. IT WAS ALSO REPORTED THAT THE PATIENT'S ANATOMY WAS NORMALLY TORTUROUS. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513991 ↗
• MalfunctionMay 28, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING PROCEDURE, THE RETRIEVER (SUBJECT DEVICE) HAD DIFFICULTY BEING ADVANCED THROUGH THE MICROCATHETER. UPON THE REMOVAL OF THE CLOT, THE RETRIEVER (SUBJECT DEVICE) WAS STUCK IN THE MICROCATHETER. LUCKILY, THE PHYSICIAN WAS ABLE TO REMOVE THE RETRIEVER (SUBJECT DEVICE) TOGETHER WITH THE MICROCATHETER AND CLOT COMPLETELY FROM PATIENT. THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3 REVASCULARIZATION WITH FIRST PASS. THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904817 ↗
• MalfunctionOct 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT RETRIEVER WAS USED DURING THE THROMBECTOMY PROCEDURE FOR THE ICA OCCLUSION. THE INTRODUCER SHEATH DISTAL END OF THE FIRST RETRIEVER LOOKED TWISTED PRIOR TO THE SECOND PASS; THEREFORE, THE PHYSICIAN NEEDED TO OPEN THE SUBJECT SECOND RETRIEVER. THE SECOND RETRIEVER WAS FRACTURED WHEN RETRACTED FROM THE VASCULATURE. THE DETACHED RETRIEVER WAS REMOVED FROM THE PATIENT ANATOMY. THE PROCEDURE WAS COMPETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10633058 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K192207, K200117, K203219, K210502, K223305. One submission often covers many models, so check the product and lot details in each record.

• Z-1905-2024 · Apr 23, 2024 · Open, Classified
  Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK