TREO Abdominal Stent-Graft System 28-L2-20-120U (UDI 08435761052166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08435761052166), received between Jan 27, 2025 and Mar 19, 2026 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Device Endoleak

  "PREVIOUSLY REPORTED AS COMPLAINT: (B)(6). BILATERAL ILIAC ARTERY GRAFT THROMBUS DISCOVERED DURING OFFICE VISIT ON (B)(6) 2023. PATIENT DEVELOPED THROMBUS ON AND ADJACENT TO STENT GRAFT WITH NO EVIDENCE OF DISTAL EMBOLUS. PATIENT WAS SUBSEQUENTLY PLACED ON ELIQUIS (5MG, 2X PER DAY), ASPIRIN (81MG PER DAY), AND ATORVASTATIN (40MG PER DAY) WITHOUT COMPLICATIONS. TPA-004-008 RETURNED FOR 1 YEAR FOLLOW-UP VISIT ON (B)(6) 2023 IN WHICH THE CTA REPORT FOUND "STABLE ANEURYSMAL SAX SIZE WITH PERSISTENT TYPE II ENDOLEAK. NEW NON-OCCLUSIVE THROMBUS IN THE PROXIMAL ASPECT OF THE LEFT COMMON ILIAC LIMB OF THE STENT-GRAFT. PER INVESTIGATOR, "PATIENT STILL HAS THROMBUS ON HIS GRAFT AND APPARENTLY IT NOW IS INVOLVING A SLIGHTLY DIFFERENT AREA THAT IT WAS BEFORE. IT IS UNCLEAR TO ME WHY THIS IS OCCURRING, AS THIS IS SOMETHING WE DO NOT GENERALLY SEE UNLESS THERE IS A LARGE DIAMETER CHANGE BETWEEN THE GRAFT COMPONENT, IT IS NOT IN THIS CASE." ADDENDUM FOR ADDITIONAL COMPLAINT 22OCT2024: THE CORE LAB SENT A NOTIFICATION ON 17OCT2024 OF SIGNIFICANT FINDING AFTER REVIEW OF SUBJECT TPA-004-008'S 2-YEAR CT IMAGING DATED ON (B)(6) 2024 NOTING A >5MM INCREASE IN ANEURYSM SAC SIZE WHEN COMPARED TO THE 30-D

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 24642799 ↗
• MalfunctionOct 24, 2025Fracture; Fracture

  "ON (B)(6) 2025, THE CORE LAB PROVIDED A SIGNIFICANT FINDING OF STENT FRACTURE REGARDING SUBJECT (B)(6) IN REVIEW OF THEIR 3-YEAR X-RAY DATED (B)(6) 2025, MORE SPECIFICALLY A BARB BREAK AT THE PROXIMAL ASPECT OF THE STENT. IN COMPARING THE 2-YEAR, THE CORE LAB FURTHER DETERMINED THE BARB BREAK WAS ALREADY PRESENT AT 2-YEAR DATED (B)(6) 2024. THE REPORT FOR THE 2-YEAR X-RAY DATED (B)(6) 2024 DID NOT SPECIFY THE BARB FRACTURE, HOWEVER THE PI CONFIRMED THE INITIAL PRESENCE AT 2-YEAR AND SEEING IT AGAIN ON THE 3-YEAR IMAGING. BOTH THE 2-YEAR CT DATED (B)(6) 2024 AND THE 3-YEAR CT DATED (B)(6) 2025 REFLECTED A PATENT DEVICE AND NO EVIDENCE OF ENDOLEAK. THE SITE REPORTED A DEVICE DEFICIENCY OCCURRING INITIALLY FOR THE 2-YEAR TIMEPOINT, AND NO ADVERSE EVENT OCCURRED AS A RESULT OF THE DEFICIENCY." PATIENT OUTCOME: "THE SUBJECT HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 AND RESULTED IN THE SUBJECT HAVING A CT AFTERWARDS (DETAILS SPECIFIED ABOVE) DUE TO THE IMAGING QUALITY OF THE DUS BEING LIMITED BY BOWEL GAS. SUBJECT IS PLANNED TO RETURN IN 1-YEAR FOR THEIR NEXT FOLLOW-UP. "

  Patient problems: Insufficient Information

  MAUDE report 23383948 ↗
• 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 (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 (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 22457941 ↗
• InjuryMar 11, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR A TYPE IIIB ENDOLEAK ON THE 2-YEAR IMAGING. PER THE CORE LAB PI, THE ENDOLEAK IS DUE TO A FABRIC TEAR. PENDING FURTHER SITE DETAILS." PATIENT OUTCOME: "THE SUBJECT WAS ASYMPTOMATIC AT THAT TIME AND NO REPORTABLE EVENTS HAVE OCCURRED AS OF ON (B)(6) 2025."

  Patient problems: Clinical Endoleak

  MAUDE report 21573225 ↗
• 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 21242891 ↗

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