TREO Abdominal Stent-Graft System 28-L2-11-140U (UDI 00843576152199)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576152199), received between Jul 11, 2025 and Jul 11, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  "THROMBOTIC OCCLUSION: THE TREO STENT-GRAFTS WERE IMPLANTED TO TREAT ABDOMINAL AORTIC ANEURYSM. AS THE RIGHT COMMON ILIAC ARTERY WAS ALSO ANEURYSMAL, THE LEG EXTENSION STENT-GRAFT CONCERNED WAS PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ENDOLEAK PRESENT. TWO MONTHS AFTER THE OPERATION, THE PATIENT RETURNED TO THE HOSPITAL WITH SOME SYMPTOMS WHERE CONTRAST ENHANCED CT REVEALED THROMBOTIC OCCLUSION IN THE RIGHT LEG EXTENSION STENT-GRAFT. AFTER THROMBECTOMY WITHIN THE STENT-GRAFT, AN ADDITIONAL BARE STENT WAS PLACED FROM THE DISTAL END OF THE LEG EXTENSION STENT-GRAFT TO THE NATIVE BLOOD VESSEL. THE PATIENT RECOVERED. PHYSICIAN'S COMMENT ON ADVERSE EVENT: IT WAS LIKELY THAT INTIMAL THICKENING HAD DEVELOPED AT THE CONTACT AREA BETWEEN NATIVE BLOOD VESSEL WALL AND THE DISTAL END OF THE LEG EXTENSION STENT-GRAFT IMPLANTED IN THE EIA (POSSIBLY DUE TO DISSECTION), CAUSING THROMBOSIS IN THE STENT GRAFT. THIS WAS NOT A COMPLICATION DUE TO A DEFECT IN THE LEG EXTENSION STENT-GRAFT. IN THE FUTURE, USE OF A BARE STENT SHOULD BE CONSIDERED WHEN THE TARGET AREA IS IN THE EIA. OPERATION TYPE: STENT-GRAFTING BLOOD LOSS: AMOUNT IS UNKNOWN. NO IM

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22482162 ↗

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