Trevo 90231Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815742002317), received between Dec 6, 2019 and Dec 22, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K131437); 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. 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-1904-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE THROMBUS RECOVERY PROCEDURE FOR MCA LESIONS, THE PHYSICIAN USED AN ACCESS CATHETER AND A MICROCATHETER TO SUCCESSFULLY DELIVER A STENT RETRIEVER. HOWEVER, THE BLOOD CLOTS REMAINED, THE PHYSICIAN USED A REPERFUSION CATHETER IN COMBINATION WITH THE SUBJECT MICROCATHETER TO ACCESS THE TREATING SITE BUT COULD NOT CROSS THE REGION. THEREFORE, BOTH DEVICES WERE WITHDRAWN. THE PHYSICIAN THEN REATTEMPTED TO APPROACH THE ANEURYSM BY COMBINING TWO CATHETERS BUT WAS UNSUCCESSFUL. THE PHYSICIAN GAVE UP TREATMENT AND IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THE SUBJECT CATHETER FRAGMENTS WERE NOTED IN THE PERIPHERAL AREA IN THE POSTOPERATIVE CT IMAGING. THE LOCATION OF CATHETER FRAGMENTS ARE UNKNOWN FOR THE SPECIFIC POSITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12332369 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ¿DELAYED REBLEEDING FROM PSEUDOANEURYSM AFTER MECHANICAL THROMBECTOMY USING STENT RETRIEVER DUE TO SMALL ARTERY AVULSION CONFIRMED BY OPEN SURGERY¿ ARTICLE STATES THAT THE PATIENT WAS PRESENTED WITH RIGHT HEMIPLEGIA AND GLOBAL APHASIA. IMAGING REVEALED OCCLUSION OF THE M2 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY WITH SUBTLE ACUTE ISCHEMIC CHANGE IN THIS TERRITORY. INTRAVENOUS THROMBOLYSIS WAS GIVEN AND MECHANICAL THROMBECTOMY WERE PERFORMED WITH THE SUBJECT STENT RETRIEVER. SUCCESSFUL REVASCULARIZATION WAS FINALLY ACHIEVED WITH A SINGLE PASS OF THE STENT RETRIEVER. DURING RETRIEVAL OF THE STENT RETRIEVER FROM THE PATIENT¿S BODY, SIGNIFICANT DEVIATION OF THE VESSEL OCCURRED AROUND MIDDLE CEREBRAL ARTERY INSIDE THE PATIENT'S ANATOMY. ANTI- COAGULATION WAS INITIATED AFTER CONFIRMING RESOLUTION OF A SMALL AMOUNT OF POST-PROCEDURAL SUB ARACHNOID HEMORRHAGE 1 DAY AFTER THE PROCEDURE. HOWEVER, 4 DAYS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF HEADACHE AND COMPUTED TOMOGRAPHY AND ANGIOGRAPHY REVEALED A MASSIVE SYLVIAN HEMATOMA WITH DE NOVO FORMATION OF A SMALL PSEUDOANEURYSM AT THE SITE WHERE THE STENT RETRIEVER WAS DEPLOYED. OPEN SURGERY BY CRANIOTOMY AND SUPERFICIAL TEMPORAL AR

  Patient problems: Headache; Hematoma; Hemorrhage, Subarachnoid; Pseudoaneurysm; Vascular Dissection

  MAUDE report 9587153 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A STENT ASSISTED-COILING PROCEDURE OF A SMALL, UN-RUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC ANEURYSM IN A RELATIVELY DYSPLASTIC VESSEL. THE STENT WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM NECK USING JAILED TECHNIQUE. THE PHYSICIAN ATTEMPTED TO DEPLOY A FIRST COIL, BUT THE COIL APPEARED TO BE TOO BIG AND LONG FOR THE ANEURYSM, AS THE COIL KEPT HERNIATING DOWNWARD INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1.5MM X 2CM COIL. UNFORTUNATELY, THE SAME ISSUE HAPPENED WITH THIS COIL AS IT CONTINUED TO HERNIATE DOWN INTO THE PARENT VESSEL. PRIOR TO DETACHING THE COIL, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO A 1MM X 1CM COIL. THIS 1MM X 1CM COIL SUCCESSFULLY DEPLOYED INTO THE ANEURYSM DOME AND WAS DETACHED. UPON INSPECTING THE COIL MASS, AS THE PHYSICIAN NOTICED THAT THERE WAS STILL OPEN SPACE IN THE MIDDLE OF THE ANEURYSM, THE PHYSICIAN DECIDED TO DEPLOY OF A SECOND 1MM X 1CM COIL INTO THE ANEURYSM DOME. UNFORTUNATELY, THIS SECOND 1MM X 1CM COIL MECHANICALLY PUSHED THE FIRST DETACHED COIL

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 9434308 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131437. One submission often covers many models, so check the product and lot details in each record.

• Z-1084-2024 · Dec 6, 2023 · Open, Classified
  Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm