TREO Abdominal Stent-Graft System 28-B2-36-080URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152397), received between May 2, 2025 and Dec 12, 2025 — 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.

• 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 23789859 ↗
• InjuryMay 2, 2025Device Endoleak; Device Endoleak

  "UP UNTIL THE BALLOONING PORTION OF THIS PROCEDURE, THE CASE HAD GONE SMOOTHLY AND WITHOUT ISSUE. THE MAIN BODY LANDED ON OUR MARKS, AND THE ILIAC LIMB EXTENSIONS LANDED JUST PROXIMAL TO THE HYPOGASTRIC OSTIUMS. A MOLDING BALLOON WAS INTRODUCED AND THE PROXIMAL SEAL WAS BALLOONED WITHOUT ISSUE. WE THEN MOVED DOWN INTO THE LEFT ILIAC LIMB AND BALLOONED ALL ALONG THE LEG FOR SEAL, NO ISSUES WERE OBSERVED. THE BALLOON WAS THEN INTRODUCED TO THE RIGHT ILIAC LIMB EXTENSION AND THE BALLOON WAS PLACED IN THE GATE TO SEAL THE PROXIMAL END OF THE LIMB EXTENSION. AS THE TECH BALLOONED THE BIFURCATION, A MUSHROOM SHAPE WAS OBSERVED. WHEN ENOUGH BALLOONING WAS EXPRESSED BY THE REP, THE TECH CONTINUED TO PUSH AND THE MUSHROOM SHAPE THEN WAS SEEN TO CHANGE INTO A FULL BALLOON SHAPE WITH A "POPPING" OBSERVATION, MUCH LIKE WHEN STABILIZING A DISSECTION. THE REST OF THE LIMB WAS MOLDED TO THE ARTERY USING A MOLDING BALLOON, WITH NO ISSUE. UPON FINAL SHOT, AN ENDOLEAK WAS OBSERVED INSIDE THE GRAFT AT THE LEVEL OF THE BIFURCATION, WE RE-BALLOONED THE BIFURCATION AND LIMBS ONLY TO CONTINUE TO SHOW EVIDENCE OF AN ENDOLEAK FROM THE SITE. WE THEN USED VBX STENTS IN ATTEMPT TO RAISE THE BIFURCATION AND SE

  Patient problems: Clinical Endoleak

  MAUDE report 21950006 ↗

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