TREO Abdominal Stent-Graft System 28-B2-26-080U (UDI 08435761052357)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08435761052357), received between Mar 31, 2025 and Jun 2, 2026 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 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 TPA-004-004'S 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 FEB 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 12MAY2026, HOWEVER AN EMBOLIZATION IS PLANNED IN THE FUTURE TO CORRECT THIS."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 25367322 ↗
• MalfunctionOct 24, 2025Fracture; Fracture

  "ON 26SEP2025, THE CORE LAB PROVIDED A SIGNIFICANT FINDING OF STENT FRACTURE REGARDING SUBJECT (B)(6) IN REVIEW OF THEIR 3-YEAR X-RAY DATED ON (B)(6) 2025, MORE SPECIFICALLY A BARB BREAK AT THE PROXIMAL ASPECT OF THE STENT. IN COMPARING THE 2-YEAR, THE CORE LAB FURTHER DETERMINED THE BARB BREAK WAS ALREADY PRESENT AT 2-YEAR DATED ON (B)(6) 2024. THE REPORT FOR THE 2-YEAR X-RAY DATED ON (B)(6) 2024 DID NOT SPECIFY THE BARB FRACTURE, HOWEVER THE PI CONFIRMED THE INITIAL PRESENCE AT 2-YEAR AND SEEING IT AGAIN ON THE 3-YEAR IMAGING. BOTH THE 2-YEAR CT DATED ON (B)(6) 2024 AND THE 3-YEAR CT DATED ON (B)(6) 2025 REFLECTED A PATENT DEVICE AND NO EVIDENCE OF ENDOLEAK. THE SITE REPORTED A DEVICE DEFICIENCY OCCURRING INITIALLY FOR THE 2-YEAR TIMEPOINT, AND NO ADVERSE EVENT OCCURRED AS A RESULT OF THE DEFICIENCY." PATIENT OUTCOME: "THE SUBJECT HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 AND RESULTED IN THE SUBJECT HAVING A CT AFTERWARDS (DETAILS SPECIFIED ABOVE) DUE TO THE IMAGING QUALITY OF THE DUS BEING LIMITED BY BOWEL GAS. SUBJECT IS PLANNED TO RETURN IN 1-YEAR FOR THEIR NEXT FOLLOW-UP. "

  Patient problems: Insufficient Information

  MAUDE report 23383947 ↗
• 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 (B)(4) IDENTIFIED A TYPE II ENDOLEAK ON PREVIOUS IMAGING. PREVIOUS 1-YEAR UNKNOWN (TYPE II OR III) ENDOLEAK LATER DEEMED TYPE IA BY INVESTIGATOR (COMPLAINT (B)(4): UPDATE 19JUN2024: ON (B)(6) 2023, THE SUB-INVESTIGATOR CONTACTED THE SUBJECT TO CONFIRM THAT IT WAS A TYPE IA ENDO

  Patient problems: Clinical Endoleak

  MAUDE report 21882992 ↗
• InjuryApr 2, 2025Device Slipped; Device Endoleak; Device Slipped; Device Endoleak

  "SUBJECT (B)(6) HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2025 WITHOUT ANY COMPLAINTS. THE CT DATED (B)(6) 2025 NOTED A PERSISTENT SUSPECTED TYPE II ENDOLEAK, CONFIRMED AS SUSPECTED BY THE INVESTIGATOR INITIALLY, PROMPTING AN ANGIO WITH POSSIBLE REINTERVENTION. THE MAX DIAMETER OF LESION WAS CONFIRMED BY THE INVESTIGATOR AS 55MM, WHICH IS THE SAME AS THE PRIOR 2-YEAR FOLLOW-UP AND <5MM INCREASE COMPARED TO 30-DAY FOLLOW-UP. THE INVESTIGATOR ADDITIONALLY NOTED A 10MM MIGRATION OF THE DEVICE, HOWEVER IT WAS STILL DEEMED PATENT. THE SUBJECT WAS ADMITTED ON (B)(6) 2025 AND UNDERWENT ANGIO WITH REINTERVENTION DUE TO WHAT WAS DETERMINED TO BE A NEW TYPE IA ENDOLEAK BY THE INVESTIGATOR. A SMALL ENDOLEAK ON THE RIGHT POSTERIOR ASPECT OF THE GRAFT WAS NOTED PROMPTING PLACEMENT OF A 30MM TERUMO AORTIC CUFF (LOT: 2402010416) PROXIMALLY. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE EVENT WAS ASSESSED AS RELATED TO DEVICE AND INDEX PROCEDURE. THE INVESTIGATOR FURTHER SPECIFIED THERE WAS NOT A DEVICE DEFICIENCY NOR DID THE REINTERVENTION OCCUR DUE TO A DEVICE DEFICIENCY." PATIENT OUTCOME: "THE SUBJECT WAS DISCHARGED ON (B)(6) 2025 IN STABLE CONDITION, BUT THE EVENT IS CURRENTLY ONGOING. ADDI

  Patient problems: Clinical Endoleak

  MAUDE report 21756273 ↗
• InjuryMar 31, 2025Insufficient Device Problem Information; Failure to Seal; Device Endoleak; Insufficient Device Problem Information; Failure to Seal; Device Endoleak

  "INITIAL IMPLANT ON (B)(6) 2023 SUCCESSFUL WITHOUT INCIDENT. UPON FOLLOW UP CT, APPEARS TO BE A COMPONENTS SEPARATION, SUPRA RENAL STENT AND FIRST SEAL STENT SEEM TO BE SEPARATED FROM THE REST OF THE STENT GRAFT. THERE IS NO TYPE IA ENDOLEAK, HOWEVER THERE ARE MULTIPLE TYPE II ENDOLEAKS WITHOUT SAC EXPANSION." PATIENT OUTCOME: "N/A"

  Patient problems: Clinical Endoleak

  MAUDE report 21730575 ↗

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