TREO Abdominal Stent-Graft System 28-L2-24-120URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152175), received between Nov 8, 2024 and Jul 9, 2025 — 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.

• InjuryJul 9, 2025Obstruction of Flow; Patient Device Interaction Problem; Failure to Seal; Device Endoleak; Obstruction of Flow; Patient Device Interaction Problem; Failure to Seal; Device Endoleak

  "ON 16JUN2025, THE CORE LAB SENT NOTIFICATION OF SIGNIFICANT FINDING FOR TPA-057-002'S 4-YEAR CT DATED ON (B)(6) 2025 THAT THERE IS A "COMPLETE STENT GRAFT OCCLUSION OF UNCLEAR ETIOLOGY COMPARED PRIOR YEAR'S IMAGING". THE SUBJECT'S 4-YEAR FOLLOW-UP OCCURRED A COUPLE MONTHS PRIOR ON (B)(6) 2025 WITH THE STUDY DATABASE NOTING THE INVESTIGATOR ASSESSED THE ENTIRE DEVICE AS NON-PATENT WITH 100% STENOSIS FOR THE MAIN BODY, LEFT LEG, AND RIGHT LEG EXTENSIONS, THEREFORE FULLY OCCLUDED. THE SUBJECT'S 3-YEAR IMAGING DATED ON (B)(6) 2024 WAS ASSESSED BY THE INVESTIGATOR AS STILL SHOWING A CHRONICALLY OCCLUDED LEFT LEG EXTENSION DESPITE PRIOR REINTERVENTION. THE EVENT HAS BEEN ASSESSED AS POSSIBLY DEVICE RELATED. THE SUBJECT HAD AN ADDITIONAL FOLLOW-UP ON (B)(6) 2025 TO FURTHER DISCUSS HIS CT RESULTS. "ANEURYSM SIZE REMAINS STABLE. STABLE TYPE II ENDOLEAK REQUIRES NO INTERVENTION. HIS AORTIC GRAFT IS OCCLUDED ALONG WITH HIS FEM-FEM. HIS CLAUDICATION IS NOT DISABLING, SO WE WILL DEFER INTERVENTION." THE SUBJECT ALSO HAS NO REST PAIN OR NUMBNESS." PATIENT OUTCOME: "THE EVENT REMAINS ONGOING AND THE SUBJECT IS PLANNED TO FOLLOW-UP IN ONE YEAR FOR FURTHER SURVEILLANCE."

  Patient problems: Clinical Endoleak; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 22457960 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Failure to Seal; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Failure to Seal; Device Endoleak

  "DOCTOR NOTIFIED ME THAT THE FOLLOW UP SCAN HAS AN ENDOLEAK. ADDITIONAL INFORMATION RECEIVED ON 10/17/2024: PROCEDURE WAS DONE YESTERDAY. WE NEVER DID AN ANGIO TO TRULY SEE IF THERE WAS A TYPE 1A VS WHAT I BELIEVE IS A TYPE 2. THE DR. ADMITTED THERE WAS A PROBABLY A TYPE 2. BUT WANTED TO TREAT AS THOUGH THERE WAS A POSSIBLE 1A ALSO. HE ENDED UP PUTTING IN 6 ENDO ANCHORS AND THEN ADDED A 28X40 TREO CUFF. PATIENT IS DOING WELL LAST I HEARD." PATIENT OUTCOME: "PATIENT SCHEDULED FOR FOLLOW UP PROCEDURE TO DETERMINE SOURCE OF ENDOLEAK AND TREAT ON (B)(6)2024"

  Patient problems: Clinical Endoleak

  MAUDE report 20640394 ↗

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