FDA recall Z-1689-2023

Bolton Medical Inc. · Class II · device

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

Status
Ongoing
Initiation date
2023-05-03
Report date
2023-06-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sunrise, FL, United States

Primary source

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