TREO Abdominal Stent-Graft System 28-B2-33-080URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052388), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (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.

• InjuryNov 12, 2025Device Endoleak; Device Endoleak

  "ON 13OCT2025, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR SUBJECT (B)(6) REFLECTING A >5MM INCREASE IN ANEURYSM SAC SIZE FOR THEIR 3-YEAR CT IMAGING DATED ON (B)(6) 2024 AS COMPARED TO 30-DAY DATED ON (B)(6) 2022. NOTE THAT THE TIMEPOINT/EVENT DATE FOR THE INITIAL INCREASE MAY BE SUBJECT TO CHANGE, AS DURING THE PROCESS OF THE CLINICAL TEAM NOTIFYING THE SITE, IT WAS IDENTIFIED THAT THE SUBJECT'S 2-YEAR CT IMAGING HAS NOT BEEN SUBMITTED TO THE CORE LAB, THEREFORE NOT YET ASSESSED. FURTHER, THE EDC DATABASE REFLECTS THAT THE 2-YEAR MEASUREMENTS ASSESSED BY THE INVESTIGATOR WAS A >5MM INCREASE WITH AN ENDOLEAK AT THAT TIME, WHILE THE SUBJECT'S 3-YEAR DATA REFLECTS NO ENDOLEAK AND A SMALLER MEASUREMENT ASSESSED BY THE INVESTIGATOR (HENCE POSSIBILITY OF INITIAL INCREASE AT 2-YEAR). THEREFORE, THE CORE LAB WILL ASSESS THE 2-YEAR IMAGING ONCE SUBMITTED BY THE SITE, AND THE CORE LAB WILL DETERMINE IF CLARIFICATION OF THE IMAGING TIMEPOINT FOR THE >5MM INCREASE FINDING IS APPROPRIATE. SITE SOURCE AND FURTHER DETAILS PENDING." PATIENT OUTCOME: "SITE SOURCE AND FURTHER DETAILS PENDING."

  Patient problems: Aneurysm expansion

  MAUDE report 23534891 ↗

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