TREO Abdominal Stent-Graft System 28-L2-15-100U (UDI 00843576152076)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152076), received between Feb 26, 2025 and Mar 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 (TYPE 4) 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 OR LATER THAT EVENING TO DUE TO A RIGHT LIMB CLOTTING

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

  MAUDE report 21621400 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  "THE CORE LAB SENT NOTIFICATION ON 03FEB2025 REGARDING SIGNIFICANT FINDING FOR SUBJECT (B)(6) 2-YEAR CT DATED (B)(6) 2024 REFLECTING A >5MM INCREASE IN ANEURYSM SAC SIZE COMPARED TO THE 30-DAY DATED (B)(6) 2022. ON (B)(6) 2024, THE SUBJECT PRESENTED FOR THEIR 2-YEAR FOLLOW-UP WITHOUT COMPLAINTS OF CLAUDICATION AND AN OVERALL STABLE VASCULAR EXAM. HIS CT REFLECTED A ~7MM INCREASE IN SAC SIZE WITH A MAX DIAMETER OF 65MM COMPARED TO THE 30-DAY CT WITH A MAX DIAMETER OF 58.5MM, AS CONFIRMED BY THE INVESTIGATOR. THE COMMON AND EXTERNAL ILIAC ARTERIES ARE PATENT. THERE IS HIGH-GRADE STENOSIS OF THE RIGHT INTERNAL ILIAC ARTERY, AND THERE IS ALSO EVIDENCE OF RIGHT INTERNAL ILIAC ARTERY ANEURYSMAL EXPANSION TO [PER INVESTIGATOR] "ABOUT 30MM ON THE SAGITTAL VIEW. THIS HAS ALWAYS MEASURED 20-24MM IN THE PAST". THERE HAS BEEN NO EVIDENCE OF ENDOLEAK ON ANY FOLLOW-UP IMAGING (30-DAY, 1-YEAR, 2-YEAR) AFTER THEIR INDEX PROCEDURE. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO DEVICE. NOTE THAT AN EVENT INVOLVING THESE DEVICES WAS PREVIOUSLY REPORTED AND INVESTIGATED UNDER COMPLAINT NUMBER (B)(4)." PATIENT OUTCOME:"THE SUBJECT IS SCHEDULED FOR A COIL EMBOLIZATION LATE (B)(6) 2025."

  Patient problems: Aneurysm expansion; Insufficient Information; Ischemia

  MAUDE report 21472764 ↗