TREO Abdominal Stent-Graft System 28-L2-15-080URecalls & reported problems

Bolton Medical Inc. · Endovascular Stent-Graft System · Class 3 · Implant

All models of TREO Abdominal Stent-Graft System (73)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843576152007), received between Oct 24, 2025 and Oct 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

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

Device problems

Adverse Event Without Identified Device or Use Problem1
Device Endoleak1

Patient problems

Aneurysm expansion1
Clinical Endoleak1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak
"ENDOLEAK: ON (B)(6) 2025, EVAR WAS SUCCESSFULLY PERFORMED. ON (B)(6) 2025, POST-OPERATIVE CT SCAN REVEALED ENDOLEAK. ON (B)(6) 2025, THE EVENT WAS REPORTED TO TC ALONG WITH PREOPERATIVE AND POSTOPERATIVE DATA. DETAILS OF THE LEG EXTENSION STENT-GRAFTS USED THE STENT-GRAFT CONCERNED: 28-L2-13-100U (LOT# 2410090253). 28-L2-15-080U (LOT# 2501070342). THE PATIENT IS CURRENTLY UNDER OBSERVATION AND NO ADDITIONAL TREATMENT IS PLANNED. OPERATION TYPE: EVAR BLOOD LOSS: UNKNOWN. IMAGE AVAILABLE IS AVAILABLE UPON REQUEST PRE-CASE PLAN AVAILABLE UPON REQUEST ADDITIONAL INFORMATION WILL BE OBTAINED UPON REQUEST DELIVERY SYSTEM WAS DISCARDED BY THE USER. (TC#(B)(4))". PATIENT OUTCOME: "IT IS UNKNOWN IF THERE WAS ANY HARM TO THE PATIENT'S HEALTH."
Patient problems: Aneurysm expansion; Clinical Endoleak
MAUDE report 23384344 ↗

Device details

UDI-DI	`00843576152007`
Brand	TREO Abdominal Stent-Graft System
Model	28-L2-15-080U
Company	Bolton Medical Inc.
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	P190015
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 11, 2026

Device type (GMDN): Aortoiliac endovascular stent-graft

A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.

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All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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