TREO Abdominal Stent-Graft System 28-C2-26-040URecalls & 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 00843576152595), received between Aug 18, 2025 and Aug 18, 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
Obstruction of Flow1

Patient problems

Aneurysm expansion1
Clinical Endoleak1
Thrombosis/Thrombus1

Recent adverse event reports

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

InjuryAug 18, 2025Obstruction of Flow; Failure to Seal; Device Endoleak; Obstruction of Flow; Failure to Seal; Device Endoleak
"TREO BIFURCATE WAS OPENED AND PREPPED AS NORMAL. THE DEVICE WAS ADVANCED, POSITIONED AND DEPLOYED AS NORMAL. CUFF WAS USED TO HELP WITH TYPE 1A ENDOLEAK. A SECOND 20X120 LIMB WAS INTRODUCED INTO THE RCIA AS THE FIRST 20X120 LIMB LANDED SHORT DUE TO TORTUOSITY. THE CASE COMPLETED AS NORMAL AND A TERUMO AORTIC BALLOON WAS USED TO ON PROXIMAL SEAL AND ALONG ALL LIMBS. FINAL ANGIO SHOWED NO EVIDENCE OF ANY LEAKS AND GOOD PERFUSION THROUGHOUT RENALS AND HYPOGASTRICS." PATIENT OUTCOME: "PHYSICIAN CONTACTED REP ON (B)(6) 2025 AS PATIENT WAS COMING INTO ER WITH LIMB THROMBOSIS AND SHORT RENAL ARTERY OCCLUSION. DR (B)(6) STATED HE WAS PLANNING TO ATTEMPT TO THROMBECTOMIZE THE LIMB WITH PENUMBRA AND RELINE WITH A STENT OR GORE."
Patient problems: Aneurysm expansion; Clinical Endoleak; Thrombosis/Thrombus
MAUDE report 22832876 ↗

Device details

UDI-DI	`00843576152595`
Brand	TREO Abdominal Stent-Graft System
Model	28-C2-26-040U
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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