TREO Abdominal Stent-Graft System 28-B2-33-100URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152465), received between Mar 17, 2025 and May 6, 2025 — classified as 2 injuries.

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

• InjuryMay 6, 2025Device Endoleak; Device Endoleak

  "THE DOCTOR CALLED ME ABOUT A PREVIOUS EVAR WHICH HAD A LEAK. AFTER IMAGES WERE ACQUIRED, IT WAS THEN REALIZED THE DEVICE WHICH WAS IMPLANTED WAS A TREO. SCAN SHOWS THAT THE AORTA HAS REMODELED. THE RENAL TO BIFURCATION LENGTH IS SIGNIFICANTLY LONGER THAN PRE EVAR SCAN. THE FABRIC LINE APPEAR TO BE ROUGHLY 7 MM BELOW THE LOWEST RENAL (RIGHT RENAL), DISEASE SEEMS TO HAVE DILATED THE NECK, AND THERE IS A TYPE 1A LEAK. THERE ALSO IS AN APPARENT TYPE 2 ENDOLEAK. THE RIGHT ILIAC LIMB SEEMS TO HAVE SUCKED UP INTO THE ANEURYSM AND VERY LITTLE IS LEFT IN THE RIGHT COMMON ILIAC ARTERY. THERE IS POTENTIAL OF A TYPE 1B LEAK." PATIENT OUTCOME: "PATIENT WILL LIKELY BE REFERRED TO ANOTHER INSTITUTE FOR A PMEG REPAIR."

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21967605 ↗
• 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 21621402 ↗

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