TREO Abdominal Stent-Graft System 28-B2-30-080U (UDI 08435761052371)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052371), received between Mar 11, 2025 and Mar 11, 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.

• InjuryMar 11, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR A TYPE IIIB ENDOLEAK ON THE 2-YEAR IMAGING. PER THE CORE LAB PI, THE ENDOLEAK IS DUE TO A FABRIC TEAR. PENDING FURTHER SITE DETAILS." PATIENT OUTCOME: "THE SUBJECT WAS ASYMPTOMATIC AT THAT TIME AND NO REPORTABLE EVENTS HAVE OCCURRED AS OF (B)(6) 2025."

  Patient problems: Clinical Endoleak

  MAUDE report 21573226 ↗

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