TREO Abdominal Stent-Graft System 28-L2-15-100U (UDI 08435761052074)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052074), received between Dec 18, 2024 and Jun 2, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Device Endoleak

  "ADDITIONAL ADDENDUM FOR (B)(6) ON LATEST FORM. SUBJECT (B)(6) 4-YEAR FOLLOW-UP OCCURRED ON (B)(6) 2026 WITH THE CT DATED ON (B)(6) 2026 REFLECTING A CONTINUED INCREASE IN ANEURYSM DUE TO A TYPE IIB ENDOLEAK. THE INVESTIGATOR ASSESSED THE MAX DIAMETER OF THE ANEURYSM AT 81MM, WHICH IS A 23MM INCREASE COMPARED TO 30-DAY (58MM) ASSESSMENT AND AN 11MM INCREASE COMPARED TO THE PREVIOUS 3-YEAR (70MM), MAKING FOR A 2ND OCCURRENCE OF >5MM ENLARGEMENT. THE SUBJECT REPORTED NO SYMPTOMS DURING THEIR FOLLOW-UP. THE SUBJECT'S LAST REINTERVENTION WAS ON (B)(6) 2025, WHICH WAS BEFORE THEIR 3-YEAR IN 2025 WHEN THE FIRST OCCURRENCE >5MM ENLARGEMENT WAS NOTED." PATIENT OUTCOME: "NO ACTION TAKEN YET AS OF ON (B)(6) 2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367324 ↗
• 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 TPA-023-011 ON(B)(6) 2024REGARDING 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 20969266 ↗

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