TREO Abdominal Stent-Graft System 28-L2-13-140U (UDI 08435761052203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052203), received between Dec 18, 2024 and Dec 18, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2024Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  "THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR SUBJECT (B)(6) ON (B)(6) 2024 REGARDING A >5MM INCREASE SAC ENLARGEMENT FOR 3-YEAR CT IMAGING DATED (B)(6) 2024 AS COMPARED TO THE 30-DAY IMAGING. THE CORE LAB'S ASSESSMENT REFLECTED A MAXIMUM ~7.7MM INCREASE. PENDING SITE DETAILS. 01" PATIENT OUTCOME: "PENDING SITE DETAILS."

  Patient problems: Aneurysm expansion

  MAUDE report 20969267 ↗

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