Trevo XP ProVue Retriever 93067Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815742000672), received between Dec 9, 2019 and Jun 9, 2020 — classified as 1 injury, 1 malfunction.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 23, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING MECHANICAL THROMBECTOMY PROCEDURE OF THE OCCLUSION ON THE RIGHT MIDDLE CEREBRAL ARTERY (M1) BY USING RETRIEVER (SUBJECT DEVICE). ON THE FOURTH AND FINAL RUN, UPON REMOVAL, THERE WAS INADVERTENT DETACHMENT OF THE RETRIEVER (SUBJECT DEVICE) INTO THE ARTERY WHICH IS PLACED BETWEEN THE PROXIMAL M2 SEGMENT AND THE ORIGIN OF THE M1 SEGMENT THAT GIVEN THE LIMITED ISCHEMIA AND INITIAL PERMEABILITY OF THE RETRIEVER (SUBJECT DEVICE). THEREFORE, IT WAS DECIDED NOT TO REMOVE THE FRAGMENT. THE MATERIAL TO DELIVER THE RETRIEVER HAS NOT BEEN PRESERVED, BUT THE RETRIEVER (SUBJECT DEVICE) IS STILL IN THE PATIENT (CURRENTLY NO PROCEDURE IS PLANNED FOR THE REMOVE, TOO MUCH RISK TO THE PATIENT). AN EMERGENCY CT (COMPUTERIZED TOMOGRAPHY) SCAN WAS PERFORMED AND INDICATED THAT THE BLEEDING IS DUE TO THE RETRIEVED (SUBJECT DEVICE) WAS DETACHED. TO STOP THE BLEEDING WAS FOLLOWED BY THE INJECTION OF A BOLUS OF ASPÉGIC 300 MH IV (PRESCRIBED TO KEEP THE RETRIEVER OPEN), BUT THIS INCREASED THE RISK OF REPERFUSION HEMORRHAGE. THE PATIENT WAS SCANNED BEFORE INTRODUCING A DOUBLE ANTIPLATELET TREATMENT WITH PLAVIX AND KARDÉGIC. MRI (MAGNETIC RESONANCE IMAGING) IMAGE SHOWED THE DEEP RIGH

  Patient problems: Device Embedded In Tissue or Plaque; Disability; Hemorrhage/Blood Loss/Bleeding; Ischemia; Neurological Deficit/Dysfunction

  MAUDE report 10136400 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT THE SUBJECT STENT RETRIEVER WAS BROKEN WHILE TRYING TO REMOVE THROMBUS FROM THE PATIENT'S ANATOMY DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 9441189 ↗