TREO Abdominal Stent-Graft System 28-B2-28-100U (UDI 08435761052449)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052449), received between Nov 25, 2024 and Mar 19, 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.

• 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 (B)(6) 2024: THE CORE LAB SENT A NOTIFICATION ON 17OCT2024 OF SIGNIFICANT FINDING AFTER REVIEW OF SUBJECT TPA (B)(4) 2-YEAR CT IMAGING DATED (B)(6) 2024 NOTING A >5MM INCREASE IN ANEURYSM SAC SIZE WHEN COMPARED TO THE 30-DAY CT

  Patient problems: Clinical Endoleak; Thrombosis/Thrombus

  MAUDE report 24642809 ↗
• InjuryNov 25, 2024Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "EVALUATED A CT SCAN FOR DR. (B)(6) ON (B)(6) 2024. ENDOLEAK WAS NOTED ON THE SCAN. POTENTIAL TYPE 3, 1A OR 2. SOURCE WAS TO BE DETERMINED POST SELECTIVE ANGIOGRAMS SCHEDULED ON (B)(6) 2023. PER MY DISCUSSION WITH DR. (B)(6), THE INITIAL TREO GRAFT WAS IMPLANTED 1CM DISTAL TO THE TAKEOFF THE LRA IN 2021. DURING THE INITIAL ANGIOGRAM PERFORMED ON (B)(6), BRISK FILLING ON THE ANEURYSM SAC WAS NOTED. DR. (B)(6) MADE THE DECISION TO PLACE A TREO CUFF TO THE LEVEL OF THE LRA (30MM X 55MM). THEREAFTER, IT WAS MOLDED USING THE CODA BALLOON AND ANOTHER ANGIOGRAM WAS TAKEN. THIS ANGIO STILL REVEALED THE LEAK. THEN THE DECISION WAS MADE TO LEAVE THE CODA BALLOON INFLATED IN THE PROXIMAL SEGMENT OF THE GRAFT/CUFF AND PLACE THE PIGTAIL CATHETER DISTAL TO THE BALLOON AND ABOVE THE FLOW-DIVIDER OF THE GRAFT. DURING THIS INJECTION, WE NOTED THE JETTING OF CONTRAST ON THE RIGHT MEDIAL SIDE OF THE TREO MAIN BODY GRAFT THROUGH THE FABRIC. THIS CONFIRMED THE TYPE 3B ENDOLEAK. DR. (B)(6) DECIDED TO CONFIRM THIS FINDING BY TAKING A BERNSTEIN CATHETER AND WAS ABLE TRAVERSE THE CATHETER THROUGH THE FABRIC TEAR OF THE GRAFT AND THEREAFTER PLACING A WIRE THROUGH THE CATHETER INTO THE ANEURYSM SAC. WAITING

  Patient problems: Clinical Endoleak

  MAUDE report 20771529 ↗

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