TREO Abdominal Stent-Graft System 28-B2-26-100U (UDI 00843576152434)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843576152434), received between Apr 7, 2025 and Feb 6, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Insufficient Device Problem Information

  "BROKEN: AFTER THE MAIN BIFURCATED STENT-GRAFT WAS IMPLANTED, LEG STENT-GRAFTS (28-L2-20-120U, 28-L2-24-100U) WERE IMPLANTED WHILE LEAVING THE DELIVERY SHEATH OF THE MAIN BIFURCATED STENT-GRAFT. AT THAT TIME, A SCREW SCREWING THE PART THAT OPENS AND CLOSES THE MECHANICAL VALVE IN THE HUB OF THE SHEATH CAME OFF, WHICH MADE IT IMPOSSIBLE TO ADJUST THE VALVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO BLOOD LOSS ANCILLARY DEVICES USED: 28-L2-20-120U, 28-L2-24-100U. IMAGE WILL BE ABLE TO BE OBTAINED PRE-CASE PLAN WILL BE ABLE TO BE OBTAINED ADDITIONAL INFORMATION WILL BE ABLE TO BE OBTAINED. ((B)(4) PATIENT OUTCOME: "NO HEALTH DAMAGE TO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283529 ↗
• InjuryNov 4, 2025Detachment of Device or Device Component; Failure to Seal; Device Endoleak; Detachment of Device or Device Component; Failure to Seal; Device Endoleak

  "SUSPECTED TYPE 3B ENDOLEAK: ON (B)(6) 2025, THE TREO MAIN BIFURCATED STENT-GRAFT WAS SUCCESSFULLY IMPLANTED. HOWEVER, A FINAL ANGIOGRAM REVEALED ENDOLEAKS, WHICH DID NOT APPEAR TO BE TYPE 1A, 1B, OR TYPE 4. ADDITIONAL BALLOON MODELING WAS APPLIED, BUT ANGIOGRAPHY STILL SHOWED THE ENDOLEAKS PERSISTED. SUSPECTING A TYPE 2 ENDOLEAK DUE TO BLOOD FLOW FROM THE RIGHT IIA, BALLOON MODELING WAS APPLIED TO THE RIGHT CIA. ANGIOGRAPHY WAS THEN PERFORMED USING A PIGTAIL ANGIOGRAPHIC CATHETER FROM WITHIN THE STENT-GRAFT, YET ENTRY OF CONTRAST MEDIA INTO THE ANEURYSM WAS STILL OBSERVED. WHEN SELECTIVE ANGIOGRAPHY WAS PERFORMED USING THE ANGIOGRAPHIC CATHETER FROM INSIDE THE STENT-GRAFT TO THE AREA WITH DENSE CONTRAST WITHIN THE ANEURYSM, CONTRAST MEDIUM WAS OBSERVED ENTERING THE ANEURYSM AS IF BLOWING OUT FROM THE STENT-GRAFT, RAISING SUSPICION OF A TYPE 3B ENDOLEAK. TO TREAT THE SUSPECTED TYPE 3B ENDOLEAK, A 28 MM EXCLUDER CUFF STENT-GRAFT WAS PLACED WITHIN THE MAIN BIFURCATED STENT-GRAFT. RE-ANGIOGRAPHY REVEALED THAT THE ENDOLEAK HAD NOT RESOLVED. AS NO OTHER DEVICES WERE AVAILABLE FOR FURTHER INTERVENTION, THE PROCEDURE WAS TERMINATED. FURTHER TREATMENT OPTIONS WILL BE CONSIDERED AFTER FOLLO

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

  MAUDE report 23463357 ↗
• MalfunctionApr 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  "KINK IN THE STENT GRAFT: WHEN CANNULATION OF THE CONTRALATERAL GATE WAS TO BE INITIATED AFTER DEPLOYMENT OF THE CONTRALATERAL GATE OF THE MAIN BIFURCATED STENT GRAFT (28-B2-26-100U), A KINK WAS OBSERVED NEAR THE AREA BETWEEN THE SECOND AND THIRD STENTS. AN ATTEMPT WAS MADE TO RESOLVE THE KINK BY ADVANCING A GUIDEWIRE FROM THE CONTRALATERAL GATE TO THE CENTRAL SIDE OF THE STENT GRAFT AND INSERTING A BALLOON. HOWEVER, BECAUSE THE AREA BETWEEN THE SECOND AND THIRD STENTS WAS NOT ALMOST OPEN, AND THE DELIVERY SYSTEM WAS STILL PRESENT, THE GUIDEWIRE DID NOT ADVANCE TO THE CENTRAL PORTION DESPITE ATTEMPTS WITH A MICRO GUIDEWIRE AND A STIFF GUIDEWIRE. IT WAS DECIDED TO DEPLOY THE IPSILATERAL LEG AND RETRIEVE THE DELIVERY SYSTEM TIP FIRST AS THE NEXT STEP. WHEN THE DELIVERY SYSTEM TIP PASSED THROUGH THE OCCLUDED AREA WITH THE KINK, THE STENT GRAFT BEHAVED AS IF IT WAS BEING PULLED, BUT THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. (FINAL ANGIOGRAPHY AFTER THE PROCEDURE ALSO SHOWED THAT THERE WAS NO MIGRATION OF THE CENTRAL SIDE OF THE STENT GRAFT.) THE BALLOON WAS ADVANCED FROM THE IPSILATERAL LEG, THE KINKED PORTION WAS DILATED, AND THE KINK WAS RESOLVED. OPERATION TYPE: EVAR ANCILLARY D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21785390 ↗

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