TREO Abdominal Stent-Graft System 28-B2-28-080U (UDI 08435761052364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08435761052364), received between Dec 26, 2024 and Jul 23, 2025 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Device Endoleak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "THE SUBJECT HAD THEIR 30-DAY FOLLOW-UP ON (B)(6) 2022 AND THEIR CT DATED (B)(6) 2022 SHOWED A TYPE IB ENDOLEAK, BUT THE SUBJECT WAS ASYMPTOMATIC OTHERWISE. THE SUBJECT UNDERWENT A REINTERVENTION ON (B)(6) 2022 INCLUDING COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY USING THREE (3) - 17CM X 6MM TERUMO AZUR COILS AND EXTENSION OF THE RIGHT ILIAC ARTERY ENDOPROSTHESIS LIMB WITH A 6MMX75MM VIABAHN SELF-EXPANDING STENT FOLLOWED BY A 7X59MM VIABAHN VBX BALLOON EXPANDABLE STENT GRAFT. THE EVENT WAS DEEMED AS RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON 0702/2025 FRO THE SITE: FOR EASE BELOW IS WHAT THE COORDINATOR SPECIFIED FROM THE IMPLANTING PHYSICIAN AS SHE GAVE ADDITIONAL DETAILS REGARDING INDEX: 1. CAN YOU SPECIFY THE LEG ASSIGNMENT (RIGHT, LEFT) FOR EACH OF LIMBS USED FOR INDEX ALONG WITH WHAT ONE WAS USED TO FURTHER EXTEND A LIMB: 1. 28-L2-13-100U LOT 2105010139 (LEFT CIA), 2. 28-L2-09-100U LOT 2108310100 (RIGHT CIA), 3. 28-L2-09-080U LOT 2108120166 (LEFT EIA EXTENSION). 2. WHICH DEVICE HAD THE TYPE IB ENDOLEAK? A. THE RIGHT SIDE. SHE HAD SHORT COMMON ILIACS AND EVEN IF WE DIDN'T HAVE A LONG LENGTH OF SEAL IN THE RIGHT ILI

  Patient problems: Clinical Endoleak

  MAUDE report 22579817 ↗
• InjuryJul 9, 2025Obstruction of Flow; Patient Device Interaction Problem; Failure to Seal; Device Endoleak; Obstruction of Flow; Patient Device Interaction Problem; Failure to Seal; Device Endoleak

  "ON 16JUN2025, THE CORE LAB SENT NOTIFICATION OF SIGNIFICANT FINDING FOR TPA-057-002'S 4-YEAR CT DATED 08MAY2025 THAT THERE IS A "COMPLETE STENT GRAFT OCCLUSION OF UNCLEAR ETIOLOGY COMPARED PRIOR YEAR'S IMAGING". THE SUBJECT'S 4-YEAR FOLLOW-UP OCCURRED A COUPLE MONTHS PRIOR ON 27MAR2025 WITH THE STUDY DATABASE NOTING THE INVESTIGATOR ASSESSED THE ENTIRE DEVICE AS NON-PATENT WITH 100% STENOSIS FOR THE MAIN BODY, LEFT LEG, AND RIGHT LEG EXTENSIONS, THEREFORE FULLY OCCLUDED. THE SUBJECT'S 3-YEAR IMAGING DATED (B)(6) 2024 WAS ASSESSED BY THE INVESTIGATOR AS STILL SHOWING A CHRONICALLY OCCLUDED LEFT LEG EXTENSION DESPITE PRIOR REINTERVENTION. THE EVENT HAS BEEN ASSESSED AS POSSIBLY DEVICE RELATED. THE SUBJECT HAD AN ADDITIONAL FOLLOW-UP ON (B)(6) 2025 TO FURTHER DISCUSS HIS CT RESULTS. "ANEURYSM SIZE REMAINS STABLE. STABLE TYPE II ENDOLEAK REQUIRES NO INTERVENTION. HIS AORTIC GRAFT IS OCCLUDED ALONG WITH HIS FEM-FEM. HIS CLAUDICATION IS NOT DISABLING, SO WE WILL DEFER INTERVENTION." THE SUBJECT ALSO HAS NO REST PAIN OR NUMBNESS." PATIENT OUTCOME: "THE EVENT REMAINS ONGOING AND THE SUBJECT IS PLANNED TO FOLLOW-UP IN ONE YEAR FOR FURTHER SURVEILLANCE."

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

  MAUDE report 22457943 ↗
• DeathMar 19, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  "ON (B)(6) 2025, THE CORE LAB SENT NOTIFICATION OF SIGNIFICANT FINDING FOR SUBJECT (B)(6) OF STENOSIS IN THE PROXIMAL GRAFT FOR 3-YEAR IMAGING DATED (B)(6) 2024 AND UNSCHEDULED IMAGING DATED (B)(6) 2024. THE UNSCHEDULED IMAGING WAS OBTAINED DURING THE SAME HOSPITALIZATION FOR THE INITIAL >5MM INCREASE NOTED ON THEIR LATE 2-YEAR IMAGING." PATIENT OUTCOME: "THE SUBJECT WAS HOSPITALIZED AGAIN AND DEATH OCCURRED ON (B)(6) 2024 DUE TO SEPTIC SHOCK UNRELATED TO THE STUDY."

  Patient problems: Restenosis; Stenosis

  MAUDE report 21643520 ↗
• InjuryDec 26, 2024Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak

  "ON (B)(6) 2023, SUBJECT (B)(6) HAD THEIR 2-YEAR REMOTE FOLLOW-UP. THE 2-YEAR CT REPORT DATED (B)(6) 2023 NOTED THE WORSENING PERSISTENT TYPE II ENDOLEAK 'LIKELY ASSOCIATED WITH THE INFERIOR MESENTERIC ARTERY' WITH 2MM INCREASE TO 52MM SINCE THE 1-YEAR FOLLOW-UP (MEASUREMENT STILL LESS THAN THE 30-DAY CT). AFTER FURTHER REVIEW OF THE CT, THE INVESTIGATOR CONFIRMED THE TYPE IIB ENDOLEAK AND HE ALSO HAD CONCERNS OF A POSSIBLE TYPE IB ENDOLEAK IN THE LEFT LIMB PROMPTING PLANS FOR AN ANGIO WITH POSSIBLE REPAIR OF THE ENDOLEAKS. ON (B)(6) 2024, THE SUBJECT WAS ADMITTED AND UNDERWENT AN ANGIO CONFIRMING THE INVESTIGATOR'S SUSPICION. A COIL EMBOLIZATION WAS PERFORMED TO CORRECT THE TYPE IIB USING A RUBY COIL AND TWO PACKING COILS AT THE NIDUS OF THE ENDOLEAK, ALONG WITH PLACEMENT OF A 13X80MM TREO LIMB EXTENSION IN THE LEFT ILIAC LIMB TO CORRECT THE TYPE IB ENDOLEAK. THE TYPE IB ENDOLEAK WAS DEEMED POSSIBLY RELATED TO DEVICE (SPECIFICALLY ILIAC LEG) AND RELATED TO THE PROCEDURE. THE TYPE II ENDOLEAK WAS DEEMED RELATED TO THE PROCEDURE ONLY. A DEVICE DEFICIENCY WAS ALSO REPORTED FOR THE TYPE IB ENDOLEAK. THE DEFICIENCY OCCURRED IN THE LEFT ILIAC LIMB (LOT 2102100148). THERE WERE NO COMPLIC

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21018048 ↗

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