TREO Abdominal Stent-Graft System 28-L2-15-160URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576152281), received between Mar 19, 2025 and May 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Endoleak” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 (B)(6) 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 22100140 ↗
• InjuryMar 19, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "I WAS NOTIFIED THAT MS. (B)(6) CAME IN ON (B)(6) 2025 EARLY IN THE MORNING WITH A RUPTURED ILIAC LIMB. UPON OPENING THE PATIENT, THE DOCTORS WERE ABLE TO CONTROL THE BLEEDING AND REPLACED THE STENT GRAFT LIMBS WITH DACRON GRAFTS. IT WAS NOTED THAT IT LOOKED TO BE THAT THE CA+ HAD ERODED INTO THE STENT GRAFT LIMBS THUS CAUSING THE LEAK. PATIENT SEEMS TO BE DOING FINE." PATIENT OUTCOME: "SHE SEEMS TO BE DOING FINE."

  Patient problems: Clinical Endoleak

  MAUDE report 21646131 ↗
• InjuryMar 19, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "I WAS NOTIFIED THAT MS. (B)(6) CAME IN ON (B)(6)2025 EARLY IN THE MORNING WITH A RUPTURED ILIAC LIMB. UPON OPENING THE PATIENT, THE DOCTORS WERE ABLE TO CONTROL THE BLEEDING AND REPLACED THE STENT GRAFT LIMBS WITH DACRON GRAFTS. IT WAS NOTED THAT IT LOOKED TO BE THAT THE CA+ HAD ERODED INTO THE STENT GRAFT LIMBS THUS CAUSING THE LEAK. PATIENT SEEMS TO BE DOING FINE." PATIENT OUTCOME: "SHE SEEMS TO BE DOING FINE."

  Patient problems: Clinical Endoleak

  MAUDE report 21646130 ↗

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