TREO Abdominal Stent-Graft System 28-L2-20-100U (UDI 00843576152090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576152090), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 3, 2023Class IIOpen, Classified

   Potential for the incorrect size stent-graft than the printed carton label.

   Z-1689-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 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 (B)(6) 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 7.2 CM, 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 03/28/2026. 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 24967241 ↗