# FDA recall Z-1689-2023

> **Bolton Medical Inc.** · Class II · device recall initiated 2023-05-03.

## Product

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-Graft and a Straight Iliac Extension  Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under fluoroscopy to the location of the infrarenal aneurysm. The stent-graft is deployed at the intended location and creates a blood flow channel, excluding the aneurysm from blood pressure and flow.

## Reason for recall

Potential for the incorrect size stent-graft than the printed carton label.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.

## Key facts

- **Recall number:** Z-1689-2023
- **Recalling firm:** Bolton Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-03
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunrise, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2023

## Citation

> AI Analytics. FDA recall Z-1689-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1689-2023. Source: US FDA. Licensed CC0.

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