Recall Z-1689-2023 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Bolton Medical Inc.
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 i
| Date | Jun 6, 2023 (initiated May 3, 2023) |
| Status | Open, Classified |
| Reason | Potential for the incorrect size stent-graft than the printed carton label. |
| Root cause | Process control |
| Action | Bolton Medical notified consignees via letter delivered through USPS Certified delivery, on 05/03/2023. Consignees were instructed to examine inventory and quarantine any affected units, complete and return the Acknowledgement Form, arrange for the return of affected units, and maintain a copy of the notification for your records. |
| Quantity | 216 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, NY, VA, WA and the countries of Italy, Great Britain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.