TREO Abdominal Stent-Graft System 28-L2-11-140U (UDI 08435761052197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435761052197), received between Apr 2, 2025 and Apr 2, 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.

• InjuryApr 2, 2025Device Slipped; Device Endoleak; Device Slipped; Device Endoleak

  "SUBJECT (B)(6) HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 WITHOUT ANY COMPLAINTS. THE CT DATED (B)(6) 2025 NOTED A PERSISTENT SUSPECTED TYPE II ENDOLEAK, CONFIRMED AS SUSPECTED BY THE INVESTIGATOR INITIALLY, PROMPTING AN ANGIO WITH POSSIBLE REINTERVENTION. THE MAX DIAMETER OF LESION WAS CONFIRMED BY THE INVESTIGATOR AS 55MM, WHICH IS THE SAME AS THE PRIOR 2-YEAR FOLLOW-UP AND <5MM INCREASE COMPARED TO 30-DAY FOLLOW-UP. THE INVESTIGATOR ADDITIONALLY NOTED A 10MM MIGRATION OF THE DEVICE, HOWEVER IT WAS STILL DEEMED PATENT. THE SUBJECT WAS ADMITTED ON (B)(6) 2025 AND UNDERWENT ANGIO WITH REINTERVENTION DUE TO WHAT WAS DETERMINED TO BE A NEW TYPE IA ENDOLEAK BY THE INVESTIGATOR. A SMALL ENDOLEAK ON THE RIGHT POSTERIOR ASPECT OF THE GRAFT WAS NOTED PROMPTING PLACEMENT OF A 30MM TERUMO AORTIC CUFF (LOT: 2402010416) PROXIMALLY. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE EVENT WAS ASSESSED AS RELATED TO DEVICE AND INDEX PROCEDURE. THE INVESTIGATOR FURTHER SPECIFIED THERE WAS NOT A DEVICE DEFICIENCY NOR DID THE REINTERVENTION OCCUR DUE TO A DEVICE DEFICIENCY." PATIENT OUTCOME: "THE SUBJECT WAS DISCHARGED ON (B)(6)2025 IN STABLE CONDITION, BUT THE EVENT IS CURRENTLY ONGOING. ADDIT

  Patient problems: Clinical Endoleak

  MAUDE report 21756272 ↗

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