TREO Abdominal Stent-Graft System 28-L2-17-100U (UDI 08435761052081)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052081), received between Mar 19, 2026 and Apr 23, 2026 — 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.

• InjuryApr 23, 2026Device Endoleak

  "I WAS MADE AWARE LAST NIGHT OF AN EXPLANT OF A TREO DEVICE, PHYSICIAN STATED THERE WAS TYPE 3 ENDOLEAK AND THE DECISION WAS MADE TO EXPLANT THE DEVICE. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 04/03/2026 FROM THE TERUMO AORTIC SITE REPRESENTATIVE: AT THE TIME OF IMPLANT BILATERAL RENAL ACCESSORIES WERE EMBOLIZED. POST IMPLANT ANGIOGRAM REVEALED SUCCESSFUL EXCLUSION OF ANEURYSM WITHOUT EVIDENCE OF ENDOLEAK. A CT PERFORMED ON (B)(6) 2021 SHOWED A POSSIBLE TYPE 2 ENDOLEAK "LIKELY DUE TO A NON-EMBOLIZED ACCESSORY LEFT RENAL", SAC WAS STABLE. HE HAD MULTIPLE INTERVENTIONS FOR A TYPE 2 ENDOLEAK WHICH LED TO A LAPAROSCOPIC LIGATION OF IMA AND MULTIPLE LUMBARS ON (B)(6) 2024. HE HAD A CV MRA ON (B)(6) 2025 THAT SHOWED SAC 7.2CM, THE REPORT ALSO STATED "RIGHT COMMON ILIAC- DISTAL SEGMENT IS ECTATIC, THE ILIAC LIMB OF AORTOILIAC STENT GRAFT EXTENDS INTO THE COMMON ILIAC ARTERY. INCOMPLETE APPOSITION OF THE DISTAL END OF THE STENT GRAFT." EXPLANT PERFORMED (B)(6) 2026. ON THE OP REPORT IT STATES 'SIGNIFICANT BLEEDING WAS NOTED FROM A DEFECT IN THE GRAFT FROM THE POSTERIOR MAIN BODY'" PATIENT OUTCOME: "NO INFO PROVIDED ON PATIENT. ADDITIONAL INFORMATION RECEIVED ON

  Patient problems: Clinical Endoleak

  MAUDE report 24967239 ↗
• InjuryMar 19, 2026Device Endoleak

  "PREVIOUSLY REPORTED AS COMPLAINT (B)(4). 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 (B)(6) 2024 NOTING A >5MM INCREASE IN ANEURYSM SAC SIZE WHEN COMPARED TO THE 30-DAY C

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 24642815 ↗

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