TREO Abdominal Stent-Graft System 28-L2-20-080U (UDI 00843576152021)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576152021), received between Jan 24, 2026 and Jan 24, 2026 — classified as 1 injury.

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.

• InjuryJan 24, 2026Adverse Event Without Identified Device or Use Problem

  "VESSEL INJURY: DURING EVAR, A MAIN BIFURCATED STENT GRAFT, THE RIGHT LEG EXTENSION STENT GRAFT AND A LEFT LEG EXTENSION STENT GRAFT WERE IMPLANTED IN THIS ORDER. AFTER IMPLANTATION, A TOUCH-UP BALLOONING WAS PERFORMED, FOLLOWED BY A FINAL ANGIOGRAPHY. AFTER ANGIOGRAPHY, THE BLOOD PRESSURE DECREASED, AND A RUPTURE OF THE RIGHT CIA WAS IDENTIFIED. ANOTHER LEG EXTENSION STENT GRAFT WAS IMPLANTED, EXTENDING UP TO THE EIA, AND THE IIA WAS LIGATED. THIS SLIGHTLY IMPROVED THE BLOOD PRESSURE. HOWEVER, THIS WAS NOT A DEFINITIVE TREATMENT, SO A VESSEL PATCH WAS ANASTOMOSED TO THE CIA TO STABILIZE THE BLOOD PRESSURE. THE PROCEDURE WAS THEN COMPLETED. PHYSICIAN'S COMMENT: ALTHOUGH THE CAUSALITY OF THE DEVICE IS UNCLEAR, IT IS PRESUMED THAT BALLOONING CAUSED THE VESSEL TO RUPTURE. OPERATION TYPE: EVAR, BLOOD LOSS: AMOUNT IS UNKNOWN, NO IMAGE AVAILABLE DUE TO HOSPITAL POLICY, NO PRE-CASE PLAN AVAILABLE DUE TO HOSPITAL POLICY, NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. (TC#BM251213147)". PATIENT OUTCOME: "THE PATIENT RECOVERED."

  Patient problems: Perforation of Vessels

  MAUDE report 24174898 ↗

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