Trevo NXT 90313Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327299939), received between Feb 11, 2021 and Mar 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.

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.

• MalfunctionMar 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE IN A PATIENT, WHILE RETRIEVING THE SUBJECT STENT INTO THE ASPIRATION CATHETER, THE CORE WIRE OF THE SUBJECT STENT RETRIEVER BROKE OFF INSIDE THE ASPIRATION CATHETER. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT ANATOMY BY REMOVING THE ASPIRATION CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570037 ↗
• MalfunctionJun 25, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT DEVICE RETRIEVER DETACHED OUT OF DELIVERY WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ONE PASS TICI 3 WAS ACHIEVED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072206 ↗
• MalfunctionFeb 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE FOR AIS (ACUTE ISCHEMIC STROKE), DISTAL ACCESS CATHETER AND MICROCATHETER WERE USED. BOTH DEVICES WERE NAVIGATED TO ICA (INTERNAL CAROTID ARTERY) BY GUIDEWIRE. THE SUBJECT RETRIEVER WAS THEN ADVANCED AND PASSED THROUGH THE THROMBUS OF M1. PHYSICIAN THEN NOTED THAT THERE WAS STRONG RESISTANCE WHEN ADVANCING SUBJECT RETRIEVER INSIDE THE CATHETER DURING ONE PASS. IT WAS REPORTED THAT PATIENT¿S ICA WAS HIGHLY TORTUOUS. WHEN THE THROMBUS WAS COLLECTED AND VISUALLY CONFIRMED THE PHYSICIAN NOTED THAT THE STENT PORTION OF THE SUBJECT STENT RETRIEVER HAD ONE WIRE BROKEN AND PROTRUDING OUTWARD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WAS NOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362779 ↗
• MalfunctionFeb 11, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS RESISTANCE WHEN A RETRIEVER (SUBJECT DEVICE) WAS INSERTED INSIDE A MICROCATHETER. IT WAS ALSO REPORTED THAT IT WAS DIFFICULT FOR THE PHYSICIAN TO REMOVE THE SUBJECT RETRIEVER FROM THE PATIENT'S ANATOMY. 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 11312146 ↗

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