TREO Abdominal Stent-Graft System 28-L2-09-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761052043), received between Apr 2, 2025 and Mar 31, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  "SUBJECT (B)(6) WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DURING THE 1-YEAR WINDOW FOR RIGHT LEG PAIN, BURNING PAIN IN RIGHT HIP AREA, FOLLOWED BY PAIN DOWN HIS LEG, AND THAT THE RIGHT LEG WAS COLD TO THE TOUCH WITH SYMPTOMS STARTING ON THE 14TH. A CT ON (B)(6) 2022 REFLECTED AN OCCLUSION OF THE RIGHT ILIAC ARTERY AND THE SUBJECT UNDERWENT REINTERVENTION VIA ARTERIAL THROMBOLYSIS WITH AN EKOS CATHETER IN THE RIGHT COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL ARTERIES." PATIENT OUTCOME: "SUBJECT WAS DISCHARGED HOME ON (B)(6) 2022. THE SUBJECT HAS HAD NO ENDOLEAKS NOR ANY FURTHER ADVERSE EVENTS TO DATE THROUGH 3-YEAR FOLLOW-UP IN 2025."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24746907 ↗
• InjuryJul 23, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "THE SUBJECT HAD THEIR 30-DAY FOLLOW-UP ON (B)(6) 2022 AND THEIR CT DATED (B)(6) 2022 SHOWED A TYPE IB ENDOLEAK, BUT THE SUBJECT WAS ASYMPTOMATIC OTHERWISE. THE SUBJECT UNDERWENT A REINTERVENTION ON (B)(6) 2022 INCLUDING COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY USING THREE (3) - 17CM X 6MM TERUMO AZUR COILS AND EXTENSION OF THE RIGHT ILIAC ARTERY ENDOPROSTHESIS LIMB WITH A 6MMX75MM VIABAHN SELF-EXPANDING STENT FOLLOWED BY A 7X59MM VIABAHN VBX BALLOON EXPANDABLE STENT GRAFT. THE EVENT WAS DEEMED AS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 0702/2025 FRO THE SITE: FOR EASE BELOW IS WHAT THE COORDINATOR SPECIFIED FROM THE IMPLANTING PHYSICIAN AS SHE GAVE ADDITIONAL DETAILS REGARDING INDEX: 1. CAN YOU SPECIFY THE LEG ASSIGNMENT (RIGHT, LEFT) FOR EACH OF LIMBS USED FOR INDEX ALONG WITH WHAT ONE WAS USED TO FURTHER EXTEND A LIMB: 1. 28-L2-13-100U LOT 2105010139 (LEFT CIA), 2. 28-L2-09-100U LOT 2108310100 (RIGHT CIA), 3. 28-L2-09-080U LOT 2108120166 (LEFT EIA EXTENSION). 2. WHICH DEVICE HAD THE TYPE IB ENDOLEAK? A. THE RIGHT SIDE. SHE HAD SHORT COMMON ILIACS AND EVEN IF WE DIDN'T HAVE A LONG LENGTH OF SEAL IN THE RIGHT ILI

  Patient problems: Clinical Endoleak

  MAUDE report 22579855 ↗
• InjuryApr 2, 2025Device Slipped; Device Endoleak; Device Slipped; Device Endoleak

  "(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. ADDITIONAL SITE

  Patient problems: Clinical Endoleak

  MAUDE report 21756271 ↗

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