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Bolton Medical Inc. recalls The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Gr
Recalled June 14, 2023 · FDA recall Z-1689-2023 · Bolton Medical
Hazard
Potential for the incorrect size stent-graft than the printed carton label. · FDA Class II
Units
216 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland.
Description
Potential for the incorrect size stent-graft than the printed carton label.
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.
Manufacturer(s)
Bolton Medical Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →