TREO Abdominal Stent-Graft System 28-L2-13-120URecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843576152137), received between Mar 17, 2025 and Apr 22, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Endoleak” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 3, 2023Class IIOpen, Classified

   Potential for the incorrect size stent-graft than the printed carton label.

   Z-1689-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Detachment of Device or Device Component

  "AFTER DEPLOYING THE LIMB AND REMOVAL OF THE DEVICE, THE NOSECONE HAD SEPARATED FROM THE DEVICE. PHYSICIAN WAS ABLE TO REMOVE THE NOSECONE FROM THE PATIENT." PATIENT OUTCOME: "PATIENT IS FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957799 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  "CLOT FORMATION WITHIN THE PROXIMAL GRAFT AND LIMB THROMBOSIS OF LEFT SIDE". PATIENT OUTCOME: "RELINED LIMB".

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24591681 ↗
• 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 23789785 ↗
• InjuryMar 17, 2025Positioning Failure; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Endoleak; Positioning Failure; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Device Endoleak

  "TREO IMPLANT WAS UNEVENTFUL. DURING FINAL RUN, WE SAW THERE WAS AN ENDOLEAK, ALONG WITH WHAT APPEARS AS A TIGHT LEFT LIMB (REDUCED FLOW) AT THE GATE LEVEL. RULED OUT TYPE 1 LEAK SO FOCUSED ON THE CONNECTION AREA. BALLOONED BILATERALLY USING KISSING TECHNIQUES AND DECIDED TO ADD A LIMB ON THE LEFT SIDE TO COVER WHAT APPEARED TO BE A LEAK AT THE CONNECTION POINT. AFTER THE IMPLANT THERE WAS STILL A LEAK THAT WAS UN-IDENTIFIABLE. THE PHYSICIAN DIDN'T LOVE THE LOOK OF THE STENTS THROUGHOUT SO DECIDED TO ADD/RE-ENFORCE USING BILATERAL 8MM VBX AND POST DILATED USING KISSING 12 X 4 BALLOONS. LIMBS VISUALLY WERE OPEN AND HAD FLOW THROUGHOUT. HOWEVER, THERE WAS STILL A PERSISTENT LEAK. IT LOOKED AS IF THERE IS A POROSITY LEAK (TYPE4) BECAUSE OF HOW THE SAC FILLED WITH CONSISTENCY, OR MAYBE IT COULD BE A TEAR IN THE FABRIC CAUSING A TYPE 3. WE EXHAUSTED ALL TROUBLESHOOTING TO IDENTIFY WHERE THE LEAK WAS COMING FROM WITH NO SUCCESS. THE PHYSICIAN DECIDED TO LET THE PATIENT LEAVE AND BRING THE PATIENT BACK FOR A FOLLOW UP CTA WITHIN THE NEXT MONTH TO TRY AND IDENTIFY WHAT'S GOING ON." PATIENT OUTCOME: "PATIENT DID NEED TO COME BACK TO THE OPERATING ROOM LATER THAT EVENING TO DUE TO A RIGHT LI

  Patient problems: Clinical Endoleak; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 21621399 ↗