TREO Abdominal Stent-Graft System 28-L2-20-120U (UDI 00843576152168)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576152168), received between Aug 18, 2025 and Apr 3, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  "OCCLUSION: ON (B)(6) 2025, THE TREO STENT-GRAFT WAS IMPLANTED AND PREOPERATIVE CT SHOWED NO PROBLEMS. HOWEVER, ABOUT A YEAR LATER, CONTRAST-ENHANCED CT REVEALED OCCLUSION IN THE LEG STENT-GRAFT. THE PATIENT HAS NO DIFFICULTIES WALKING. THE PHYSICIAN IS CONSIDERING PERFORMING A FEMORAL-FEMORAL BYPASS PROCEDURE IN THE NEAR FUTURE. OPERATION TYPE: UNKNOWN BLOOD LOSS: UNKNOWN ANCILLARY DEVICES USED: TREO STENT-GRAFTS (28-B2-30-100U AND 28-L2-17-100U) UNKNOWN WHETHER IMAGE IS AVAILABLE PRE-CASE PLAN AVAILABLE (SEE THE ATTACHED SCHEMA) UNKNOWN WHETHER ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. (TC# (B)(4). PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781558 ↗
• 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): 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 23441549 ↗
• InjuryAug 18, 2025Obstruction of Flow; Failure to Seal; Device Endoleak; Obstruction of Flow; Failure to Seal; Device Endoleak

  "TREO BIFURCATE WAS OPENED AND PREPPED AS NORMAL. THE DEVICE WAS ADVANCED, POSITIONED AND DEPLOYED AS NORMAL. CUFF WAS USED TO HELP WITH TYPE 1A ENDOLEAK. A SECOND 20X120 LIMB WAS INTRODUCED INTO THE RCIA AS THE FIRST 20X120 LIMB LANDED SHORT DUE TO TORTUOSITY. THE CASE COMPLETED AS NORMAL AND A TERUMO AORTIC BALLOON WAS USED TO ON PROXIMAL SEAL AND ALONG ALL LIMBS. FINAL ANGIO SHOWED NO EVIDENCE OF ANY LEAKS AND GOOD PERFUSION THROUGHOUT RENALS AND HYPOGASTRICS." PATIENT OUTCOME: "PHYSICIAN CONTACTED REP ON (B)(6) 2025 AS PATIENT WAS COMING INTO ER WITH LIMB THROMBOSIS AND SHORT RENAL ARTERY OCCLUSION. DR (B)(6) STATED HE WAS PLANNING TO ATTEMPT TO THROMBECTOMIZE THE LIMB WITH PENUMBRA AND RELINE WITH A STENT OR GORE."

  Patient problems: Aneurysm expansion; Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 22832893 ↗

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