TREO Abdominal Stent-Graft System 28-B2-22-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576152410), received between Oct 24, 2025 and Oct 24, 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.

• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "ENDOLEAK: ON (B)(6) 2025, EVAR WAS SUCCESSFULLY PERFORMED. ON (B)(6) 2025, POST-OPERATIVE CT SCAN REVEALED ENDOLEAK. ON (B)(6) 2025, THE EVENT WAS REPORTED TO TC ALONG WITH PREOPERATIVE AND POSTOPERATIVE DATA. DETAILS OF THE LEG EXTENSION STENT-GRAFTS USED THE STENT-GRAFT CONCERNED: 28-L2-13-100U (LOT# 2410090253), 28-L2-15-080U (LOT# 2501070342). THE PATIENT IS CURRENTLY UNDER OBSERVATION AND NO ADDITIONAL TREATMENT IS PLANNED. OPERATION TYPE: EVAR BLOOD LOSS: UNKNOWN. IMAGE AVAILABLE IS AVAILABLE UPON REQUEST, PRE-CASE PLAN AVAILABLE UPON REQUEST, ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST, DELIVERY SYSTEM WAS DISCARDED BY THE USER. (TC# (B)(4). PATIENT OUTCOME: "IT IS UNKNOWN IF THERE WAS ANY HARM TO THE PATIENT'S HEALTH."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23384345 ↗

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