TREO Abdominal Stent-Graft System 28-B2-28-100U (UDI 00843576152441)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576152441), received between Jul 28, 2025 and Jan 9, 2026 — classified as 2 injuries.

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

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem; Device Endoleak

  "ENDOLEAK (TYPE III B / IV): ON (B)(6), AFTER COIL EMBOLIZATION OF THE IMA DURING ELECTIVE OPERATION, THE 28MM MAIN BIFURCATED STENT-GRAFT WAS IMPLANTED VIA THE RIGHT FEMORAL ARTERY, THE LEFT CONTRALATERAL LEG EXTENSION STENT-GRAFT 17MM-120MM WAS IMPLANTED VIA A 14FR INTRODUCER SHEATH (DRYSEAL, GORE), AND THEN THE RIGHT IPSILATERAL LEG EXTENSION STENT-GRAFT 17MM-100MM WAS IMPLANTED. AFTER THE PLACEMENT, BALLOON MODELING WAS PERFORMED. FINAL ANGIOGRAPHY REVEALED AN ENDOLEAK. TO PREVENT A TYPE 3A ENDOLEAK, ADDITIONAL BALLOON MODELING WAS PERFORMED FOR THE OVERLAP BETWEEN THE MAIN BIFURCATED STENT-GRAFT AND THE LEG EXTENSION STENT-GRAFTS, AND ANGIOGRAPHY WAS PERFORMED TO IDENTIFY THE CAUSE OF THE ENDOLEAK. DURING THIS BALLOON MODELING, THE BALLOON RUPTURED. AS THE ENDOLEAK PERSISTED, IT WAS DETERMINED TO BE A TYPE 4 ENDOLEAK, AND THE PROCEDURE WAS TERMINATED. ON (B)(6), A CONTRAST ENHANCED CT SCAN REVEALED WHAT APPEARED TO BE CONTRAST LEAKAGE FROM THE BODY OF THE MAIN BIFURCATED STENT-GRAFT, PROMPTING CONSIDERATION OF ADDITIONAL TREATMENT. ON (B)(6), THE DAY OF THE ADDITIONAL TREATMENT, THE DISTRIBUTOR CONTACTED TC'S SALES REPRESENTATIVE, WHO LEARNED OF THIS EVENT, INCLUDING THE ADDIT

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

  MAUDE report 24028752 ↗
• InjuryJul 28, 2025Detachment of Device or Device Component; Failure to Seal; Device Endoleak; Detachment of Device or Device Component; Failure to Seal; Device Endoleak

  "ENDOLEAK (PROBABILITY OF TYPE IV IS HIGH, BUT NOT DEFINITE): AFTER EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY AND IMA, EVAR WAS PERFORMED AS PLANNED AND THE STENT-GRAFTS WERE SUCCESSFULLY PLACED. HOWEVER, ENDOLEAK WAS DETECTED DURING THE FINAL ANGIOGRAPHY. AS THE DISTAL END OF THE IPSILATERAL GATE WAS TO LAND IN THE EXTERNAL ILIAC ARTERY, THE MAIN BIFURCATED STENT-GRAFT WAS POSITIONED BASED ON THE LOCATION OF THE DISTAL END OF THE IPSILATERAL GATE. AS A RESULT, THE PROXIMAL END OF THE IPSILATERAL LEG EXTENSION STENT-GRAFT WAS DEPLOYED FROM 1 CM DISTAL TO THE CONTRALATERAL MAXIMUM OVERLAP MARKER. (THIS LOCATION WAS WITHIN THE SPECIFICATIONS OF THE IFU, WHICH SHOULD HAVE ENSURED AN OVERLAP OF APPROXIMATELY 3 CM). ON THE FIRST FINAL ANGIOGRAPHY, WITH RESPECT TO THE ABOVE FACTORS, THE ENDOLEAK APPEARED TO BE TYPE 3A, AS THE LEAK APPEARED TO BE BLOWING OUT FROM THE JUNCTION OF THE MAIN BIFURCATED STENT-GRAFT AND THE IPSILATERAL LEG EXTENSION STENT-GRAFT. AN ADDITIONAL LEG EXTENSION STENT-GRAFT ONE SIZE LONGER WAS PLACED AS A LINING INSIDE THE IPSILATERAL LEG EXTENSION STENT-GRAFT, EXTENDING THE COVERAGE BY ONE CM DISTALLY AND ONE CM PROXIMALLY EACH. THIS RESOLVED THE BLOW-LIKE END

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

  MAUDE report 22638483 ↗