TREO Abdominal Stent-Graft System 28-L2-13-080U (UDI 00843576151994)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: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843576151994), received between May 19, 2025 and May 1, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Detachment of Device or Device Component1
Device Endoleak1
Mechanical Problem1

Patient problems

Clinical Endoleak1
Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMay 1, 2026Device Endoleak
"POSSIBLE TYPE 3 FABRIC TEAR AT LEAVEL OF LIMB LOCK POST IMPLANT OF CONTRALATERAL LIMB, LIMB ADDED TO FIX ENDOLEAK" PATIENT PUTCOME: "PATIENT DOING WELL."
Patient problems: Clinical Endoleak
MAUDE report 25056952 ↗
MalfunctionMay 19, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
"DURING THE PROCEDURE THE NOSE CONE OF THE TREO ILIAC LIMB BROKE OFF AND NEEDED TO BE RETRIEVED USING A SNARE FROM FLOATING IN THE AORTA. THERE WERE NO TA REPS PRESENT AND THE DEVICE WAS PULLED FROM CONSIGNMENT STOCK. DR (B)(6) REPORTED TO ME (B)(6) AND (B)(6) VIA TEXT AFTER THE PROCEDURE. ILIAC DEVICE WAS PUSHED THROUGH A SOMEWHAT TIGHT AND TORTUOUS ILIAC. DEVICE WAS ABLE TO BE DEPLOYED AND WHILE REMOVING THE DELIVERY SYSTEM THE NOSE CONE BECAME DISLODGED. THE DOCTOR WAS ABLE (AFTER MANY HOURS) TO RETRIEVE AND SAFELY REMOVE THE NOSE CONE. PATIENT IS DOING FINE AND DEVICE IS BEING SHIPPED TO TA." PATIENT OUTCOME: "NO ADDITIONAL PATIENT INJURY WAS REPORTED."
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22047528 ↗

Device details

UDI-DI	`00843576151994`
Brand	TREO Abdominal Stent-Graft System
Model	28-L2-13-080U
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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