TREO Abdominal Stent-Graft System 28-B2-26-100U (UDI 08435761052432)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761052432), received between Dec 6, 2024 and Mar 31, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  "SUBJECT (B)(6) WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 DURING THE 1-YEAR WINDOW FOR RIGHT LEG PAIN, BURNING PAIN IN RIGHT HIP AREA, FOLLOWED BY PAIN DOWN HIS LEG, AND THAT THE RIGHT LEG WAS COLD TO THE TOUCH WITH SYMPTOMS STARTING ON THE 14TH. A CT ON (B)(6) 2022 REFLECTED AN OCCLUSION OF THE RIGHT ILIAC ARTERY AND THE SUBJECT UNDERWENT REINTERVENTION VIA ARTERIAL THROMBOLYSIS WITH AN EKOS CATHETER IN THE RIGHT COMMON ILIAC, EXTERNAL ILIAC, AND COMMON FEMORAL ARTERIES." PATIENT OUTCOME: "SUBJECT WAS DISCHARGED HOME ON (B)(6) 2022. THE SUBJECT HAS HAD NO ENDOLEAKS NOR ANY FURTHER ADVERSE EVENTS TO DATE THROUGH 3-YEAR FOLLOW-UP IN 2025."

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24746908 ↗
• InjuryJan 14, 2026Device Endoleak

  "SUBJECT (B)(6) HAD THEIR 3-YEAR FOLLOW-UP ON (B)(6) 2024 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 (B)(6) 2025 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 24067101 ↗
• InjuryDec 6, 2024Device Stenosis; Device Stenosis

  "SUBJECT TPA-008-003 HAD THEIR 3-YEAR FOLLOW-UP ON(B)(6)2024 AND RECENTLY DEVELOPED INCREASING CLAUDICATION SYMPTOMS ON THE RIGHT LEG THAT WERE DEBILITATING AND DIAGNOSED AS PROGRESSIVE EXTERNAL ILIAC OCCLUSIVE DISEASE. THE CT DATED (B)(6)2024 REFLECTED NO ENDOLEAKS, HOWEVER PER THE PI, THE CT "INDICATED THE ENDOGRAFT IN GOOD POSITION WITH SUCCESSFUL EXCLUSION OF ANEURYSM BUT THERE WAS A HIGH-GRADE STENOSIS OF THE OUTFLOW RIGHT EXTERNAL ILIAC ARTERY IN ITS PROXIMAL SEGMENT. THIS WAS FELT TO BE SEVERE AND COULD COMPROMISE FUNCTION IN THE GRAFT". ADDITIONALLY, THE STENOSIS "EXCEEDED 80% IF NOT 90%" POSING A RISK OF OCCLUSION WITH PROBABLE THROMBOSIS OF THE RIGHT LIMB OF THE GRAFT AND SEVERE ISCHEMIA. ON (B)(6)2024, THE SUBJECT UNDERWENT OUTPATIENT SURGERY INVOLVING AN ANGIOPLASTY WITH A 7MM BALLOON AND STENTING OF RIGHT EXTERNAL ILIAC ARTERY USING A 12X4 SMART STENT. THERE WERE NO COMPLICATIONS AND THE COMPLETION ANGIO REFLECTED THE RIGHT EXTERNAL ILIAC ARTERY AS WIDELY PATENT WITH NO RESIDUAL NARROWING." PATIENT OUTCOME: "THE SUBJECT WAS SEEN ON (B)(6)2024 AND HAD AN ULTRASOUND (US) ANKLE/BRACHIAL CONDUCTED SAME DAY REFLECTING AN IMPROVED ANKLE BRACHIAL INDEX (ABI) ON THE RIGHT SIDE

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20860927 ↗

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