TREO Abdominal Stent-Graft System 28-L2-13-100U (UDI 00843576152069)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843576152069), received between Mar 19, 2025 and Mar 31, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  "SUBJECT (B)(6) WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DURING THE 1-YEAR WINDOW FOR RIGHT LEG PAIN, BURNING PAIN IN RIGHT HIP AREA, FOLLOWED BY PAIN DOWN HIS LEG, AND THAT THE RIGHT LEG WAS COLD TO THE TOUCH WITH SYMPTOMS STARTING ON THE 14TH. A CT ON (B)(6) 2022 REFLECTED AN OCCLUSION OF THE RIGHT ILIAC ARTERY AND THE SUBJECT UNDERWENT REINTERVENTION VIA ARTERIAL THROMBOLYSIS WITH AN EKOS CATHETER IN THE RIGHT COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL ARTERIES." PATIENT OUTCOME: "SUBJECT WAS DISCHARGED HOME ON (B)(6) 2022. THE SUBJECT HAS HAD NO ENDOLEAKS NOR ANY FURTHER ADVERSE EVENTS TO DATE THROUGH 3-YEAR FOLLOW-UP IN 2025."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24746909 ↗
• InjuryDec 12, 2025Device Endoleak; Device Endoleak

  "PATIENT RETURNED FOR FOLLOW UP VISIT ROUGHLY 6 WKS POST OP. PRESENTED WITH ENDOLEAK IN THE LIMBS OF MAIN BODY. DO NOT KNOW YET HOW PHYSICIAN WILL PROCEED WITH SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 11/14/2025: IT IS A TYPE 3 ENDOLEAK. NOT SURE IF 3A OR 3B AS THE GRAFT IS NOT SEPARATED TO SAY IT IS CONFIRMED 3A. HOWEVER, IT COULD BE LEAKING BETWEEN THE PIECES OR SOME LEAK DUE TO FABRIC INTEGRITY. NOT SURE YET. THIS PATIENT DID HAVE MAXIMUM OVERLAP WITH THE DEVICES." PATIENT OUTCOME: "PATIENT IS OK CAME IN FOR ROUTINE FOLLOW UP".

  Patient problems: Clinical Endoleak

  MAUDE report 23789786 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "ENDOLEAK: ON (B)(6) 2025, EVAR WAS SUCCESSFULLY PERFORMED. ON (B)(6) 2025, POST-OPERATIVE CT SCAN REVEALED ENDOLEAK. ON (B)(6) 2025, THE EVENT WAS REPORTED TO TC ALONG WITH PREOPERATIVE AND POSTOPERATIVE DATA. DETAILS OF THE LEG EXTENSION STENT-GRAFTS USED THE STENT-GRAFT CONCERNED: 28-L2-13-100U (LOT#: 2410090253). 28-L2-15-080U (LOT#: 2501070342). THE PATIENT IS CURRENTLY UNDER OBSERVATION AND NO ADDITIONAL TREATMENT IS PLANNED. OPERATION TYPE: EVAR. BLOOD LOSS: UNKNOWN. IMAGE AVAILABLE IS AVAILABLE UPON REQUEST. PRE-CASE PLAN AVAILABLE UPON REQUEST. ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST. DELIVERY SYSTEM WAS DISCARDED BY THE USER. (TC#: (B)(4))". PATIENT OUTCOME: "IT IS UNKNOWN IF THERE WAS ANY HARM TO THE PATIENT'S HEALTH."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23384342 ↗
• InjuryJun 9, 2025Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  "OCCLUSION DUE TO SUSPECTED POOR PATENCY ON THE DISTAL SIDE OF THE LEG STENT-GRAFT: THE TREO WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA), AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ENDOLEAK. AFTER THE PROCEDURE, THE PATIENT VISITED THE HOSPITAL COMPLAINING OF DISCOMFORT AND INABILITY TO MOVE HIS LEG. AS LEG OCCLUSION WAS SUSPECTED, AN ADDITIONAL PROCEDURE WAS PERFORMED ON MAY 14. A THROMBUS WAS REMOVED, AND THE CONTRAST MEDIUM WAS CONFIRMED TO FLOW. AS A PRECAUTION, A VBX STENT-GRAFT (GORE) AND AN EPIC VASCULAR STENT (BOSTON SCIENTIFIC) WERE IMPLANTED TO ENSURE BLOOD FLOW. THE PATIENT RECOVERED AND IS NOW ABLE TO MOVE HIS LEG. PHYSICIAN'S COMMENT: IN THE PAST, THE PHYSICIAN USED AN OVERSIZED ENDURANT STENT-GRAFT, WHICH RESULTED IN INFOLDING OF THE STENT-GRAFT AND FORMING OF A THROMBUS. SINCE THE TREO LEG STENT-GRAFT HAD THE SAME Z-SHAPED DESIGN AS THE ENDURANT STENT-GRAFT, THE SAME PROBLEM MAY HAVE OCCURRED THIS TIME. HOWEVER, SINCE THE APPROPRIATE DEVICE WAS SELECTED FOR THE VESSEL DIAMETER THIS TIME, ALTHOUGH THE CAUSE IS NOT CLEAR, IT IS ASSUMED THAT THERE WAS A STENOSIS AT THE ORIGIN OF THE IIA AND THE STENT-GRAFT WAS WRINKLED DUE TO INFOLDING, RESUL

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22170137 ↗
• InjuryMar 19, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "I WAS NOTIFIED THAT MS. (B)(6) CAME IN ON (B)(6) 2025 EARLY IN THE MORNING WITH A RUPTURED ILIAC LIMB. UPON OPENING THE PATIENT, THE DOCTORS WERE ABLE TO CONTROL THE BLEEDING AND REPLACED THE STENT GRAFT LIMBS WITH DACRON GRAFTS. IT WAS NOTED THAT IT LOOKED TO BE THAT THE CA+ HAD ERODED INTO THE STENT GRAFT LIMBS THUS CAUSING THE LEAK. PATIENT SEEMS TO BE DOING FINE." PATIENT OUTCOME: "SHE SEEMS TO BE DOING FINE."

  Patient problems: Clinical Endoleak

  MAUDE report 21646132 ↗
• InjuryMar 19, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "I WAS NOTIFIED THAT MS. (B)(6) CAME IN ON (B)(6) 2025 EARLY IN THE MORNING WITH A RUPTURED ILIAC LIMB. UPON OPENING THE PATIENT, THE DOCTORS WERE ABLE TO CONTROL THE BLEEDING AND REPLACED THE STENT GRAFT LIMBS WITH DACRON GRAFTS. IT WAS NOTED THAT IT LOOKED TO BE THAT THE CA+ HAD ERODED INTO THE STENT GRAFT LIMBS THUS CAUSING THE LEAK. PATIENT SEEMS TO BE DOING FINE." PATIENT OUTCOME: "SHE SEEMS TO BE DOING FINE."

  Patient problems: Clinical Endoleak

  MAUDE report 21646129 ↗

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