TREO Abdominal Stent-Graft System 28-L2-20-080U (UDI 08435761052029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052029), received between Jan 14, 2026 and Jun 5, 2026 — classified as 2 injuries.

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

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.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  "ON 11MAY2026, THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING REGARDING >5MM GROWTH OF SUBJECT'S AORTA AT PROXIMAL ASPECT OF THE STENT FOR THEIR 3-YEAR CT DATED (B)(6) 2025 IN COMPARISON TO THE 30-DAY TIMEPOINT. THE INVESTIGATOR REVIEWED THE FINDING AND SUBJECT'S IMAGING AND DID NOT AGREE WITH THE CORE LAB'S ASSESSMENT, SPECIFYING THE FOLLOWING: "SUBJECT HAS NO CHANGE IN THE AORTIC NECK FROM IMPLANTATION. MEASUREMENT OF THE NECK ON THE AXIAL IMAGE ATTACHED OVERCALLS THE DIAMETER THAT IS INDEED ANEURYSMAL AT THE TOP OF THE UNCOVERED STRUTS OF THE TREO GRAFT. THERE IS ANGULATION THAT IS MAKING THAT DIAMETER LARGER THAN IT REALLY IS AND IS BEST SEEN IN THE SAGITTAL VIEW FOR MEASUREMENT. ON DIRECT COMPARISON OF THE INITIAL AND MOST RECENT CT, THERE IS NO CHANGE IN THE NECK AT THE TOP OF THE UNCOVERED STRUTS OR AT THE SHORT RING LIKE SEAL ZONE OF THE NECK SINCE IMPLANTATION. NO FURTHER ACTION IS REQUIRED." THE CSM INQUIRED AFTERWARDS WITH THE CORE LAB REGARDING THE SITE'S ASSESSMENT, AND CORE LAB SPECIFIED THAT PER THEIR CORE LAB PI "PROXIMAL AORTIC GROWTH IS PRESENT IN THE PROXIMAL ASPECT OF THE STENT BUT STILL APPEARS TO HAVE SEAL WITH MINIMAL GRAFT MOVEMENT". THE CORE LAB AL

  Patient problems: Aneurysm expansion

  MAUDE report 25416062 ↗
• InjuryJan 14, 2026Device Endoleak

  "SUBJECT (B)(6) HAD THEIR 3-YEAR FOLLOW-UP ON 03DEC2024 WITH THE PI CONFIRMING THAT THEIR CT DATED (B)(6) 2024 REFLECTED A >5MM INCREASE IN ANEURYSM MEASURING 74MM AS COMPARED TO THE 30-DAY CT DATED (B)(6) 2022 WITH A MEASUREMENT OF 64MM (10MM INCREASE OVERALL). THROUGH 2-YEAR FOLLOW-UP THE SUBJECT'S ANEURYSM HAS REMAINED STABLE; HOWEVER, THEY HAVE HAD A TYPE IIA ENDOLEAK SINCE THE 1-YEAR FOLLOW-UP THAT DID NOT WORSEN UNTIL 3-YEAR FOLLOW-UP." PATIENT OUTCOME: "EVENT IS ONGOING AND NO ACTION HAS BEEN TAKEN TO DATE, THEREFORE NO SERIOUS CRITERIA MET. THE SUBJECT HAD THEIR 4-YEAR FOLLOW-UP ON 28OCT2025 WITH THE MAX ANEURYSM DIAMETER REMAINING STABLE WITH AN INVESTIGATOR MEASUREMENT OF 74.8MM. THE INVESTIGATOR CONFIRMED THAT THERE ARE NO PLANS TO INTERVENE AT THIS TIME."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24067095 ↗

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