TREO Abdominal Stent-Graft System 28-L2-13-080U (UDI 08435761051992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761051992), received between Apr 22, 2025 and Jun 2, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Endoleak” (3 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.

• InjuryJun 2, 2026Device Endoleak

  "ADDITIONAL ADDENDUM FOR AAA-0732 ON LATEST FORM. SUBJECT (B)(6) 4-YEAR FOLLOW-UP OCCURRED ON (B)(6) 2026 WITH THE CT DATED (B)(6) 2026 REFLECTING A CONTINUED INCREASE IN ANEURYSM DUE TO A TYPE IIB ENDOLEAK. THE INVESTIGATOR ASSESSED THE MAX DIAMETER OF THE ANEURYSM AT 81MM, WHICH IS A 23MM INCREASE COMPARED TO 30-DAY (58MM) ASSESSMENT AND AN 11MM INCREASE COMPARED TO THE PREVIOUS 3-YEAR (70MM), MAKING FOR A 2ND OCCURRENCE OF >5MM ENLARGEMENT. THE SUBJECT REPORTED NO SYMPTOMS DURING THEIR FOLLOW-UP. THE SUBJECT'S LAST REINTERVENTION WAS IN (B)(6) 2025, WHICH WAS BEFORE THEIR 3-YEAR IN 2025 WHEN THE FIRST OCCURRENCE >5MM ENLARGEMENT WAS NOTED." PATIENT OUTCOME: "NO ACTION TAKEN YET AS OF (B)(6) 2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367321 ↗
• InjuryApr 22, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "IN (B)(6) 2024, THE SUBJECT'S 2-YEAR IMAGING NOTED A NEW TYPE IIB ENDOLEAK AS CONFIRMED BY THE INVESTIGATOR. THEN ON (B)(6) 2024, THE SUBJECT HAD AN ADDITIONAL CT PERFORMED WHICH SHOWED AN UNCHANGED SAC SIZE, HOWEVER WAS CONFIRMED BY THE INVESTIGATOR AS A TYPE IIB ENDOLEAK AND DEEMED SIGNIFICANT AT THAT POINT PROMPTING TREATMENT TO CORRECT. THE SUBJECT WAS ADMITTED ON (B)(6) 2025 TO CORRECT THE TYPE IIB ENDOLEAK SAME DAY VIA COIL EMBOLIZATION. MULTIPLE SIZE COILS WERE PLACED IN THE ANEURYSM SAC AS WELL AS ALONG THE LENGTH OF THE INFERIOR MESENTERIC ARTERY. A FLUSH SMA ARTERIOGRAM WAS PERFORMED AND DEMONSTRATED IT AS WIDELY PATENT. THERE WERE NO COMPLICATIONS. THE SUBJECT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2025. NOTE: THERE HAVE NOT BEEN ANY TYPE II ENDOLEAKS IDENTIFIED BY THE INVESTIGATOR ON ANY IMAGING UNTIL THE 2-YEAR OCCURRED IN MAY 2024, HOWEVER THE INTERNAL INVESTIGATION FOR COMPLAINT (B)(6) IDENTIFIED A TYPE II ENDOLEAK ON PREVIOUS IMAGING. PREVIOUS 1-YEAR UNKNOWN (TYPE II OR III) ENDOLEAK LATER DEEMED TYPE IA BY INVESTIGATOR (B)(6): UPDATE 19JUN2024: ON 21SEP2023, THE SUB-INVESTIGATOR CONTACTED THE SUBJECT TO CONFIRM THAT IT WAS A TYPE IA ENDOLEAK AND WAS REF

  Patient problems: Clinical Endoleak

  MAUDE report 21882991 ↗
• InjuryApr 22, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "IN (B)(6) 2024, THE SUBJECT'S 2-YEAR IMAGING NOTED A NEW TYPE IIB ENDOLEAK AS CONFIRMED BY THE INVESTIGATOR. THEN ON (B)(6) 2024, THE SUBJECT HAD AN ADDITIONAL CT PERFORMED WHICH SHOWED AN UNCHANGED SAC SIZE, HOWEVER WAS CONFIRMED BY THE INVESTIGATOR AS A TYPE IIB ENDOLEAK AND DEEMED SIGNIFICANT AT THAT POINT PROMPTING TREATMENT TO CORRECT. THE SUBJECT WAS ADMITTED ON (B)(6) 2025 TO CORRECT THE TYPE IIB ENDOLEAK SAME DAY VIA COIL EMBOLIZATION. MULTIPLE SIZE COILS WERE PLACED IN THE ANEURYSM SAC AS WELL AS ALONG THE LENGTH OF THE INFERIOR MESENTERIC ARTERY. A FLUSH SMA ARTERIOGRAM WAS PERFORMED AND DEMONSTRATED IT AS WIDELY PATENT. THERE WERE NO COMPLICATIONS. THE SUBJECT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2025. NOTE: THERE HAVE NOT BEEN ANY TYPE II ENDOLEAKS IDENTIFIED BY THE INVESTIGATOR ON ANY IMAGING UNTIL THE 2-YEAR OCCURRED IN (B)(6) 2024, HOWEVER THE INTERNAL INVESTIGATION FOR COMPLAINT AAA-0517 IDENTIFIED A TYPE II ENDOLEAK ON PREVIOUS IMAGING. PREVIOUS 1-YEAR UNKNOWN (TYPE II OR III) ENDOLEAK LATER DEEMED TYPE IA BY INVESTIGATOR ((B)(4)): UPDATE 19JUN2024: ON (B)(6) 2023, THE SUB-INVESTIGATOR CONTACTED THE SUBJECT TO CONFIRM THAT IT WAS A TYPE IA ENDOLEAK AN

  Patient problems: Clinical Endoleak

  MAUDE report 21882990 ↗

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