Recall Z-1689-2023— Bolton Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by Bolton Medical Inc., 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: Potential for the incorrect size stent-graft than the printed carton label..
- Recalling firm
- Bolton Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-03
- Firm location
- Sunrise, FL, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.