TREO Abdominal Stent-Graft System 28-L2-13-140U (UDI 00843576152205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152205), received between May 28, 2025 and Feb 4, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

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.

• InjuryFeb 4, 2026Failure to Seal; Device Endoleak

  "ENDLEAK (TYPE III) AFTER THE TREO LEG STENT-GRAFT WAS IMPLANTED, BALLOON MODELING WAS PERFORMED THROUGHOUT THE STENT-GRAFT USING A MOB BALLOON (GORE). AN ANGIOGRAPHY THEN REVEALED A LEAK FROM THE OVERLAPPING PORTION BETWEEN THE CONTRALATERAL SIDE OF THE MAIN BIFURCATED STENT-GRAFT AND THE TREO LEG STENT-GRAFT. TO DETERMINE THE TYPE OF LEAK, AN ANGIOGRAPHY WAS PERFORMED BY DELIVERING A CATHETER INSIDE THE STENT-GRAFT. A TYPE 3A OR 3B ENDOLEAK FROM THE LEFT LEG WAS SUSPECTED. AN EXCLUDER LEG STENT-GRAFT (GORE, 14 MM) WAS ADDITIONALLY IMPLANTED AT THE SUSPECTED LEAK SITE. THE TYPE 3 (A OR B) ENDOLEAK THEN DISAPPEARED. HOWEVER, A TYPE 4 ENDOLEAK PERSISTED. IT WAS DECIDED THAT THE PATIENT WOULD BE PLACED UNDER OBSERVATION, AND THE PROCEDURE WAS COMPLETED. OPERATION TYPE: EVAR BLOOD LOSS: UNKNOWN ANCILLARY DEVICES USED: RADIFOCUS GUIDEWIRE (EXTRA STIFF WIRE), PIGTAIL-SHAPED CATHETER WITH MARKER, DRYSEAL INTRODUCER SHEATH (GORE, 18 FR, 14 FR), MOB BALLOON CATHETER (GORE). IMAGE AVAILABLE UPON REQUEST PRE-CASE PLAN AVAILABLE UPON REQUEST ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. (TC# (B)(4) PATIENT OUTCOME: "THE PATIENT WAS PLACED UNDER OBSERVATION."

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260284 ↗
• InjuryMay 28, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING ON (B)(6) 2025 FOR SUBJECT TPA-026-001 REGARDING A >5MM INCREASE SAC ENLARGEMENT FOR 2-YEAR IMAGING DATED (B)(6) 2024 AS COMPARED TO THE 30-DAY IMAGING. THE 2-YEAR CT WAS NON-CONSTRAST, THEREFORE THE CORE LAB ALSO USED THE RECENT 3-YEAR CT WITH/WITHOUT CONTRAST FOR COMPARISON OF CONTINUED GROWTH AS NOTED ON THE FINDING. PENDING SITE DETAILS". PATIENT OUTCOME: "PENDING SITE DETAILS".

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22100139 ↗

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