TREO Abdominal Stent-Graft System 28-B2-30-080U (UDI 00843576152373)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152373), received between Mar 11, 2025 and Oct 31, 2025 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Device Endoleak; Device Endoleak

  "POSSIBLE HOLE IN THE FABRIC FROM INITIAL IMPLANT. PLANNING TO ADD LIMBS BILATERALLY TO RAISE BIFURCATION. UPDATE ON 10/07/2025 FROM (B)(6) READER: THE PHYSICIAN BROUGHT THE PATIENT BACK ON SATURDAY (B)(6) 2025 AND IT WAS IN FACT TYPE 4, HOLE IN GRAFT OR SOME SORT OF TEAR. WE USED (2) 15X80 LIMBS TO RAISE THE BIFURCATION AND IT SEALED." PATIENT OUTCOME: "I SPOKE TO THE PHYSICIAN YESTERDAY (B)(6) 2025) AND HE IS DOING GREAT. BACK PAIN HAS BEEN RESOLVED AND HE WAS DISCHARGED ON SUNDAY (B)(6) 2025)".

  Patient problems: Clinical Endoleak

  MAUDE report 23441555 ↗
• MalfunctionMar 11, 2025Mechanical Jam; Difficult or Delayed Separation; Mechanical Jam; Difficult or Delayed Separation

  "THE PHYSICIAN IMPLANTED THE DEVICE UNDER NORMAL CIRCUMSTANCES THROUGH A 20FR COOK SHEATH. HE DEPLOYED THE DEVICE AND WENT TO RELEASE THE PROXIMAL CLASP BY ENGAGING THE GREY GRIP RELEASE HOLDER. THE GREY GRIP WOULD NOT MOVE. HE PUSHED VERY HARD FORWARD AND IT WOULD STILL NOT RELEASE. I MADE SURE HE WAS NOT HINDERING THE BLACK RELEASE IN ANY WAY. HE THEN TRIED MOVING IT WITH LARGE CLAMPS BUT THAT ALSO DID NOT RELEASE IT. HE THEN BROKE OFF SIDES OF THE BLACK GRIP WITH HEMASTATS AND WAS ABLE TO PULL THE BLACK GRIP BACK AND RELEASE THE PROXIMAL CLASP." PATIENT OUTCOME: "THE DEVICE WAS THEN FULLY RELEASED AND THE PATIENT IS DOING FINE AT LAST CHECK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573209 ↗