Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants Recalled by Bolton Medical Inc. Due to Potential for the incorrect size stent-graft than the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bolton Medical Inc. directly.
Affected Products
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.
Quantity: 216 units
Why Was This Recalled?
Potential for the incorrect size stent-graft than the printed carton label.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bolton Medical Inc.
Bolton Medical Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report