TREO Abdominal Stent-Graft System 28-B2-28-080U (UDI 00843576152366)Recalls & 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 00843576152366), received between Feb 10, 2025 and Feb 10, 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

Device Endoleak1
Failure to Seal1

Patient problems

Clinical Endoleak1

Recent adverse event reports

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

InjuryFeb 10, 2025Failure to Seal; Device Endoleak; Failure to Seal; Device Endoleak
"TREO BIFUR WAS OPENED AND PREPPED AS NORMAL. THE DEVICE WAS ADVANCED, POSITIONED AND DEPLOYED AS NORMAL. FOLLOWING CONTRALATERAL GATE CANNULATION, THE PROXIMAL CLASP WAS RELEASED, AND LASER FENESTRATIONS WERE CREATED FOR THE RIGHT AND LEFT RENAL ARTERIES. BRIDGING STENTS WERE PLACED IN EACH RENAL AND FLARED ACCORDINGLY. THE IPSILATERAL LEG WAS FULLY DEPLOYED, COMPLETING DEPLOYMENT OF THE TREO BIFUR AND THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AS NORMAL. THE CONTRALATERAL AND IPSILATERAL LIMBS WERE DETERMINED, OPENED AND PREPPED AS NORMAL. THE CONTRALATERAL LIMB WAS ADVANCED, POSITIONED AND DEPLOYED AS NORMAL. THE IPSILATERAL LIMB WAS ADVANCED, POSITIONED JUST ABOVE THE MINIMUM OVERLAP MARKER AND DEPLOYED AS NORMAL. A TERUMO AORTIC BALLOON WAS PREPPED, ADVANCED, AND ONLY USED IN THE OVERLAP BETWEEN THE BIFUR LEGS AND LIMBS, AS WELL AS THE DISTAL SEAL ZONES ON BOTH SIDES. NO BALLOONING ABOVE THE FABRIC LINE OF EACH LIMB OCCURRED AT THIS TIME. ON THE COMPLETION ANGIOGRAM AN ENDOLEAK WAS OBSERVED. IT WAS UNCLEAR WHERE THE LEAK WAS COMING FROM. THE PHYSICIAN BALLOONED THE MAIN BODY OF THE TREO BIFUR BELOW THE RENAL ARTERY STENTS AND THE ENTIRE CONTRALATERAL SIDE USING THE TERUM
Patient problems: Clinical Endoleak
MAUDE report 21350088 ↗

Device details

UDI-DI	`00843576152366`
Brand	TREO Abdominal Stent-Graft System
Model	28-B2-28-080U
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	Apr 30, 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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