TREO Abdominal Stent-Graft System 28-L2-24-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761052104), received between Oct 17, 2024 and Mar 19, 2025 — classified as 2 deaths, 1 injury.

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.

• DeathMar 19, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  "ON 28FEB2025, THE CORE LAB SENT NOTIFICATION OF SIGNIFICANT FINDING FOR SUBJECT (B)(6) OF STENOSIS IN THE PROXIMAL GRAFT FOR 3-YEAR IMAGING DATED (B)(6) 2024 AND UNSCHEDULED IMAGING DATED (B)(6) 2024. THE UNSCHEDULED IMAGING WAS OBTAINED DURING THE SAME HOSPITALIZATION FOR THE INITIAL >5MM INCREASE NOTED ON THEIR LATE 2-YEAR IMAGING." PATIENT OUTCOME: "THE SUBJECT WAS HOSPITALIZED AGAIN AND DEATH OCCURRED ON (B)(6) 2024 DUE TO SEPTIC SHOCK UNRELATED TO THE STUDY.

  Patient problems: Restenosis; Stenosis

  MAUDE report 21643571 ↗
• 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 TPA-004-002 WAS CONTACTED ON 27MAR2024 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 21242893 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "SUBJECT (B)(6) HAD THEIR 2-YEAR FOLLOW-UP ON (B)(6) 2024 WITH A CT DATED (B)(6) 2024 WHICH SHOWED A TINY EXTRAVASATION AT POSTERIOR ASPECT OF LEFT ILIAC LIMB FOR POSSIBLE ENDOLEAK (CONFIRMED AS TYPE IA ENDOLEAK BY THE INVESTIGATOR), RIGHT COMMON ILIAC ARTERY (CIA) DISSECTION AND 100MM X 94MM ANEURYSM. ON (B)(6) 2024, THE INVESTIGATOR MET WITH THE SUBJECT AGAIN TO FURTHER DISCUSS TREATMENT OPTIONS. HE STATED A FEVAR WITH PMEG WOULD BE MOST APPROPRIATE AS THE LONG TERUMO MAIN BODY WOULD ALLOW PMEG PLACEMENT MORE READILY THAN A STANDARD EVAR. AN ADDITIONAL CT DATED (B)(6) 2024 NOTED THE ANEURYSM WAS 'ESSENTIALLY UNCHANGED MEASURING 98MM', THE PREVIOUSLY DESCRIBED ENDOLEAK WAS LESS CONSPICUOUS, AND THE RIGHT CIA DISSECTION WAS ALSO UNCHANGED. ON (B)(6) 2024, THE SUBJECT UNDERWENT A FEVAR USING A PMEG DEVICE AND COIL EMBOLIZATION ON THE RIGHT INTERNAL ILIAC ARTERY. THE PMEG WAS IMPLANTED IN THE SMA AND BILATERAL RENAL ARTERIES ON A BIFURCATED MODULAR PLATFORM WITH 4 FENESTRATIONS AND 3 BRIDGING STENTS. THE COIL EMBOLIZATION WAS PERFORMED USING A 10MM POD DEVICE. THE SUBJECT WAS ADMITTED SAME-DAY FOR OBSERVATION." PATIENT OUTCOME - "THE EVENT WAS CONSIDERED AS RESOLVED AT TIME OF DISCHA

  Patient problems: Clinical Endoleak; Vascular Dissection

  MAUDE report 20474863 ↗

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