TREO Abdominal Stent-Graft System 28-B2-24-080U (UDI 08435761052340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761052340), received between Dec 3, 2024 and Jul 27, 2026 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Fracture

  "The Core Lab sent notification on (b)(6) 2026 having identified a barb break at the proximal aspect of the uncovered stent for subject (b)(6) 4-year imaging dated (b)(6) 2026. Additional information received on 07/02/2026:The subject's 4-year follow-up occurred same day and remains asymptomatic from an aneurysmal perspective without Endo leaks and stable size of residual aneurysm sac. There were no AEs that occurred as a result of this barb break identified by the Core Lab.The PI reviewed the imaging and did not identify any stent graft integrity issues, therefore no device deficiency reported by the site. The x-ray report also states 'no gross evidence of migration or stent fracture'."Patient Outciome: "Pending details from the site regarding status of subject or if any AEs have occurred as a result of."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017622 ↗
• DeathJan 27, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Device Endoleak; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Device Endoleak

  "SUBJECT (B)(6) WAS CONTACTED ON (B)(6)2024 TO SCHEDULE THEIR 2-YEAR FOLLOW-UP, AND THE SITE WAS TOLD BY THE SUBJECT'S SPOUSE THAT THE SUBJECT HAD PASSED AWAY AT HOME ON (B)(6)2024. THE CAUSE OF DEATH WAS PREVIOUSLY UNKNOWN DUE TO SIGNIFICANT SITE DIFFICULTIES OBTAINING ANY SOURCE. THE DEATH CERTIFICATE WAS RECENTLY OBTAINED CONFIRMING THE DATE OF DEATH AND CAUSE OF DEATH STATES ABDOMINAL AORTIC ANEURYSM. THE DEVICE RELATEDNESS IS PENDING ASSESSMENT BY THE PRINCIPAL INVESTIGATOR. FURTHER, THE SITE IS STILL ATTEMPTING TO OBTAIN POSSIBLE HOSPITALIZATION SOURCE FROM AN OUTSIDE INSTITUTION WHICH OCCURRED SHORTLY PRIOR TO THE SUBJECT'S DEATH TO FURTHER REVIEW AGAINST THE DEATH CERTIFICATE." PATIENT OUTCOME: "SUBJECT DEATH AS NOTED ABOVE."

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

  MAUDE report 21242892 ↗
• InjuryDec 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  "SUBJECT (B)(6) HAD THEIR 3-YEAR FOLLOW-UP ON 03JUL2024 WHERE IT WAS NOTED THAT HE HAD NO CHANGES IN HEALTH OTHER THAN NEW CLAUDICATION IN HIS LEFT LEG. THE CT DATED (B)(6) 2024 REFLECTED A NEW COMPLETE OCCLUSION OF THE LEFT ILIAC LIMB WHICH WAS 100% PATENT ON THEIR 2-YEAR IMAGING DATED (B)(6) 2023. THE REMAINDER OF THE DEVICE WAS PATENT, COMPLETE SAC REGRESSION, AND NO ENDOLEAK. DISTAL TO THE STENT GRAFT, THE LEFT COMMON, EXTERNAL, AND INTERNAL ILIAC ARTERIES ARE PATENT LIKELY VIA COLLATERALS. THE INVESTIGATOR DEEMED THE EVENT SERIOUS FOR THE CRITERIA "PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION", AND RELATED TO THE DEVICE, SPECIFICALLY ILIAC LEG. THE SUBJECT STATED THAT THE CLAUDICATION SYMPTOMS WERE NOT SEVERE ENOUGH AND DENIED SURGERY TO CORRECT IT AT THAT TIME. THE SUBJECT AGREED TO NOTIFY THE SITE IF HE DECIDED TO HAVE HIS CLAUDICATION TREATED IN THE FUTURE." PATIENT OUTCOME: "AS OF NOVEMBER 2024, THE SUBJECT HAS NOT CONTACTED THE SITE NOR HAD ANY ADDITIONAL FOLLOW-UPS TO DISCUSS PLANS FOR RE-INTERVENTION."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20831430 ↗

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