TREO Abdominal Stent-Graft System 28-L2-11-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08435761052050), received between Dec 5, 2024 and Dec 5, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Stenosis” (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 5, 2024Device Stenosis; Device Stenosis

  "(B)(6) 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 AND NO FURT

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 20858394 ↗
• InjuryDec 5, 2024Device Stenosis; Device Stenosis

  "SUBJECT (B)(6) 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 20857814 ↗

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