Recall Z-3042-2018 ยท HBT Applier, Hemostatic Clip
LeMaitre Vascular, Inc.
AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
| Date | Jun 19, 2018 |
| Status | Terminated |
| Reason | The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are not cleared by the FDA for devices distributed in the United States: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue. |
| Root cause | Under Investigation by firm |
| Action | On June 19, 2018, the firm sent Urgent Medical Device Recall letters to affected consignees. The letters informed customers of the product labeling issue. Customers were asked to complete the customer reply form and return it to the firm, and to forward the recall to any other facilities where product had been distributed. After the customer service department receives the completed form, they will contact the customer to arrange for a return of the recalled product at no charge to the customers. Customer service will also arrange for customers to receive replacement product. If you have any |
| Distribution | Distributed to accounts in FL, NV, OK, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173323 | AnastoClip GC Closure System LeMaitre Vascular, Inc., Mar 8, 2018 |