TREO Abdominal Stent-Graft System 28-L2-13-100U (UDI 08435761052067)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08435761052067), received between Dec 26, 2024 and Feb 26, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 TPA-021-001'S 2-YEAR CT DATED (B)(6) 2024 REFLECTING A >5MM INCREASE IN ANEURYSM SAC SIZE COMPARED TO THE 30-DAY DATED 07NOV2022. 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). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY (B)(6) ON (B)(6) 2025, THE SUBJ

  Patient problems: Aneurysm expansion; Insufficient Information; Ischemia

  MAUDE report 21472765 ↗
• 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 21018049 ↗
• 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 ON (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 COM

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21018047 ↗

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