TREO Abdominal Stent-Graft System 28-B2-30-100U (UDI 08435761052456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052456), received between Dec 18, 2024 and Feb 26, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  "THE CORE LAB SENT NOTIFICATION ON 03FEB2025 REGARDING SIGNIFICANT FINDING FOR SUBJECT TPA-021-001'S 2-YEAR CT DATED (B)(6) 2024 REFLECTING A >5MM INCREASE IN ANEURYSM SAC SIZE COMPARED TO THE 30-DAY DATED 07NOV2022. ON (B)(6) 2024, THE SUBJECT PRESENTED FOR THEIR 2-YEAR FOLLOW-UP WITHOUT COMPLAINTS OF CLAUDICATION AND AN OVERALL STABLE VASCULAR EXAM. HIS CT REFLECTED A ~7MM INCREASE IN SAC SIZE WITH A MAX DIAMETER OF 65MM COMPARED TO THE 30-DAY CT WITH A MAX DIAMETER OF 58.5MM, AS CONFIRMED BY THE INVESTIGATOR. THE COMMON AND EXTERNAL ILIAC ARTERIES ARE PATENT. THERE IS HIGH-GRADE STENOSIS OF THE RIGHT INTERNAL ILIAC ARTERY, AND THERE IS ALSO EVIDENCE OF RIGHT INTERNAL ILIAC ARTERY ANEURYSMAL EXPANSION TO [PER INVESTIGATOR] "ABOUT 30MM ON THE SAGITTAL VIEW. THIS HAS ALWAYS MEASURED 20-24MM IN THE PAST". THERE HAS BEEN NO EVIDENCE OF ENDOLEAK ON ANY FOLLOW-UP IMAGING (30-DAY, 1-YEAR, 2-YEAR) AFTER THEIR INDEX PROCEDURE. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO DEVICE. NOTE THAT AN EVENT INVOLVING THESE DEVICES WAS PREVIOUSLY REPORTED AND INVESTIGATED UNDER COMPLAINT NUMBER (B)(4). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY (B)(6) ON (B)(6) 2025. ON 25FEB

  Patient problems: Aneurysm expansion; Insufficient Information; Ischemia

  MAUDE report 21472763 ↗
• 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 21NOV2024 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 20969268 ↗

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