TREO Abdominal Stent-Graft System 28-L2-17-120URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052159), received between Oct 24, 2025 and Oct 24, 2025 — classified as 1 malfunction.

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

• MalfunctionOct 24, 2025Fracture; Fracture

  "ON 26SEP2025, THE CORE LAB PROVIDED A SIGNIFICANT FINDING OF STENT FRACTURE REGARDING SUBJECT (B)(6) IN REVIEW OF THEIR 3-YEAR X-RAY DATED ON (B)(6) 2025, MORE SPECIFICALLY A BARB BREAK AT THE PROXIMAL ASPECT OF THE STENT. IN COMPARING THE 2-YEAR, THE CORE LAB FURTHER DETERMINED THE BARB BREAK WAS ALREADY PRESENT AT 2-YEAR DATED ON (B)(6) 2024. THE REPORT FOR THE 2-YEAR X-RAY DATED ON (B)(6) 2024 DID NOT SPECIFY THE BARB FRACTURE, HOWEVER THE PI CONFIRMED THE INITIAL PRESENCE AT 2-YEAR AND SEEING IT AGAIN ON THE 3-YEAR IMAGING. BOTH THE 2-YEAR CT DATED ON (B)(6) 2024 AND THE 3-YEAR CT DATED ON (B)(6) 2025 REFLECTED A PATENT DEVICE AND NO EVIDENCE OF ENDOLEAK. THE SITE REPORTED A DEVICE DEFICIENCY OCCURRING INITIALLY FOR THE 2-YEAR TIMEPOINT, AND NO ADVERSE EVENT OCCURRED AS A RESULT OF THE DEFICIENCY." PATIENT OUTCOME: "THE SUBJECT HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 AND RESULTED IN THE SUBJECT HAVING A CT AFTERWARDS (DETAILS SPECIFIED ABOVE) DUE TO THE IMAGING QUALITY OF THE DUS BEING LIMITED BY BOWEL GAS. SUBJECT IS PLANNED TO RETURN IN 1-YEAR FOR THEIR NEXT FOLLOW-UP. "

  Patient problems: Insufficient Information

  MAUDE report 23383946 ↗

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