TREO Abdominal Stent-Graft System 28-L2-17-080URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052012), received between Mar 19, 2025 and Mar 19, 2025 — classified as 1 death.

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

• DeathMar 19, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  "ON 28FEB2025, THE CORE LAB SENT NOTIFICATION OF SIGNIFICANT FINDING FOR SUBJECT (B)(6) OF STENOSIS IN THE PROXIMAL GRAFT FOR 3-YEAR IMAGING DATED (B)(6) 2024 AND UNSCHEDULED IMAGING DATED (B)(6) 2024. THE UNSCHEDULED IMAGING WAS OBTAINED DURING THE SAME HOSPITALIZATION FOR THE INITIAL >5MM INCREASE NOTED ON THEIR LATE 2-YEAR IMAGING." PATIENT OUTCOME: "THE SUBJECT WAS HOSPITALIZED AGAIN AND DEATH OCCURRED ON (B)(6) 2024 DUE TO SEPTIC SHOCK UNRELATED TO THE STUDY."

  Patient problems: Restenosis; Stenosis

  MAUDE report 21643512 ↗

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