AnastoClip GC Closure System — Class II medical device recall Z-3042-2018
Terminated recall by LeMaitre Vascular, Inc., reported 2018-09-19, distributed in FL, NV, OK, SC, TX. The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lis
| Recall number | Z-3042-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2018-06-19 |
| Classified | 2018-09-13 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2019-04-17 |
| Distributed | FL, NV, OK, SC, TX |
| Reason classes | unapproved product |
| Model numbers | 4007-08 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3042-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.