TREO Abdominal Stent-Graft System 28-B2-26-120URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152519), received between Jan 3, 2025 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

1 other recall cover devices cleared under the same FDA submission (P190015); 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 18, 2026.

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.

• MalfunctionJul 8, 2025Output Problem; Positioning Problem

  GRAFT WAS OPENED AND MODIFIED. DIFFICULTY RESHEATHING GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 22436178 ↗
• MalfunctionJan 3, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  "DESCRIBE THE EVENT OR PROBLEM: DURING THE CASE, THE TREO ABDOMINAL STENT-GRAFT SYSTEM WAS STUCK ON DELIVERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? FENESTRATED ENDOVASCULAR REPAIR OF VISCERAL AND INFRARENAL AORTA PERCUTANEOUS INCLUDING FOUR OR MORE VISCERAL ARTERY ENDOPROSTHESES WITH BIFURCATE. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ADDITIONAL INFORMATION RECEIVED ON 12/26/2024: THE DEVICE WAS IMPLANTED AND THE PATIENT IS FINE. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE PROXIMAL CLASP MOVED DOWN BUT DID NOT RELEASE THE SUPRARENAL FIXATION. THE IMAGING I HAVE AVAILABLE ALONG WITH DR. (B)(6) CASE PLAN. I WILL HAVE TO SEND THOSE IN BATCHES; THE FILE IS TOO LARGE. THIS WAS A PHYSICIAN MODIFIED DEVICE." PATIENT OUTCOME: "THE PATIENT IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072079 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190015. One submission often covers many models, so check the product and lot details in each record.

• Z-1689-2023 · May 3, 2023 · Open, Classified
  The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graf