Trevo NXT 90312Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327299922), received between Oct 7, 2020 and Mar 26, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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-1905-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVE WITH THE SUBJECT STENT, COMPUTED TOMOGRAPHY (CT) REVEALED A HYPERINTENSE AREA IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA) AND SHOWED A HIGH LIKELIHOOD OF METALLIC RESIDUE ALSO PARALYSIS WAS NOTED TO THE PATIENT AFTER THE PROCEDURE DUE TO THE REPORTED EVENT WITH THE SUBJECT DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Paralysis

  MAUDE report 24705058 ↗
• MalfunctionDec 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CEREBRAL ANGIOGRAM WITH MECHANICAL THROMBECTOMY PROCEDURE, THE SUBJECT STENT RETRIEVER WAS DIFFICULT TO REMOVE FROM THE SHEATH AFTER USE. UPON INSPECTION AFTER REMOVAL, THE DEVICE WAS CRUSHED AND MANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23711694 ↗
• MalfunctionNov 14, 2025Difficult to Remove; Material Deformation

  THE TREVO DEVICE WAS DIFFICULT TO REMOVE FROM THE SHEATH AFTER USE. UPON INSPECTION AFTER REMOVAL, THE DEVICE WAS CRUSHED AND MANGLED AND DR. [REDACTED] ASKED FOR A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553772 ↗
• InjuryOct 22, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THROMBUS RETRIEVAL AT M2 USING THE SUBJECT STENT RETRIEVER, THE VESSEL EXPERIENCED STRETCHING AFTER THE STENT RETRIEVER WAS DEPLOYED, MAKING IT IMPOSSIBLE TO RETRIEVE (THE BLOOD VESSELS EXPAND AND CONTRACT AFTER THE STENT WAS DEPLOYED, AND THE STENT RETRIEVER WAS TRAPPED IN THE VESSEL). A MICROCATHETER WAS PLACED, AND THE STENT RETRIEVER WAS RE-SHEATHED AND REDEPLOYED. HOWEVER, THE SAME STRETCHING ISSUE OCCURRED, TRAPPING THE STENT RETRIEVER AND PREVENTING THROMBUS RETRIEVAL. THE STENT RETRIEVER WAS THEN REPLACED, WHICH SUCCESSFULLY RETRIEVED THE THROMBUS WITHOUT COMPLICATIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN WHETHER THE VESSEL STRETCHING WAS CAUSED BY THE SUBJECT STENT RETRIEVER. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20507662 ↗
• InjuryAug 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING M2 THROMBECTOMY, THE OPERATOR ATTEMPTED TO DEPLOY THE SUBJECT RETRIEVER BUT MET RESISTANCE. THE OPERATOR REMOVED THE RETRIEVER AND THE MICROCATHETER. NO ISSUES WAS SEEN ON THE IMAGING. A PORTION OF THE SUBJECT RETRIEVER WAS SEEN ON THE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN DONE THE NEXT DAY. THE SUBJECT RETRIEVER BROKE OFF AND WAS LEFT INSIDE PATIENT'S ANATOMY. THE IMPACT TO THE PATIENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17627033 ↗
• MalfunctionFeb 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT RETRIEVER IN THE MICROCATHETER AND THE DELIVERY WIRE BROKE WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE SUBJECT DEVICE AND THE RETRIEVER GOT STUCK IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND RETRIEVER AND 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 16444195 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE UNRUPTURED CEREBRAL ANEURYSM CASE, PHYSICIAN DEPLOYED THE SUBJECT STENT RETRIEVER INTO THE TORTUROUS VESSEL. THE SUBJECT STENT RETRIEVER COULD NOT BE USED AND WAS REMOVED FROM THE PATIENT'S ANATOMY. POST-PROCEDURE PATIENT WAS PRESENTED WITH SEVERE STROKE (SAH). PHYSICIAN THOUGHT THAT THE ADVERSE EVENT WAS DUE TO THE SUBJECT STENT RETRIEVER DEPLOYMENT. PATIENT WAS GIVEN ANTIHYPERTENSIVE AND HEMOSTATIC MEDICATIONS. ONE MONTH LATER, PATIENT WAS RECOVERED BUT HAD SEQUELAE. NO ADDITIONAL INFORMATION AVAILABLE

  Patient problems: Hemorrhagic Stroke

  MAUDE report 15312461 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ACUTE ISCHEMIC STROKE, A THROMBECTOMY PROCEDURE USING THE STENT RETRIEVER COMBINATION TECHNIQUE IN THE LEFT MIDDLE CEREBRAL ARTERY M3 SEGMENT WAS PERFORMED. DURING THE PROCEDURE, VESSEL REPERFUSION WAS NOT ACHIEVED. PERFORATION OF BLOOD VESSELS OCCURRED WHICH WAS RELATED TO THE SUBJECT STENT RETRIEVER. ONE DAY POST PROCEDURE, THE PATIENT HAD SYMPTOMATIC INTRACRANIAL HEMORRHAGE (PH-2 PARENCHYMAL HEMATOMA) AND SUBARACHNOID HEMORRHAGE (SAH) WHICH CAUSED PROLONGATION OF EXISTING HOSPITALIZATION. INTERVENTION PERFORMED DUE TO THESE EVENTS ARE UNKNOWN. RELATIONSHIP OF PH-2 AND SAH TO SUBJECT STENT RETRIEVER AND PROCEDURE ARE ALSO UNKNOWN. PATIENT PASSED AWAY 18 DAYS POST PROCEDURE. PHYSICIAN CONFIRMED THAT PATIENT DEATH WAS NOT RELATED TO SUBJECT STENT RETRIEVER, PROCEDURE OR PRIMARY DISEASE. CAUSE OF DEATH WAS NOT PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 11496204 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BLEEDING WAS REPORTED DURING THE PROCEDURE AT A TARGET LOCATION WHERE A RETRIEVER (SUBJECT DEVICE) WAS PLACED INSIDE THE PATIENT'S ANATOMY AND N-BUTYL CYANOACRYLATE (NBCA) WAS INJECTED TO STOP BLEEDING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10645249 ↗