LeMaitre Vascular recalls AnastoClip GC Closure System (REF# 4007-08) due to incorrect instructions listing unapproved uses like closing arteriotomies and veinotomies. Affected users should check if they have the product.
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.
Take action
Contact the company
📍Recalling firmLeMaitre Vascular, Inc.63 2nd Ave · Burlington, MA 01803-4413
“LeMaitre Vascular AnastoClip GC Closure System: Wrong Instructions Risk Unapproved Uses.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70831-lemaitre-vascular-anastoclip-gc-closure-system-wrong-instructions-risk-unapproved. Based on FDA recall #Z-3042-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3042-2018%22&limit=1).
The FDA announced on June 19, 2018, that LeMaitre Vascular, Inc. is recalling the AnastoClip GC Closure System (REF# 4007-08) due to incorrect instructions for use. The wrong IFU listed indications not cleared by the FDA for devices distributed in the United States.
How to tell if you have it
Brand: LeMaitre Vascular
Product: AnastoClip GC Closure System
REF#: 4007-08
Lot code: AGC2134
Distribution: Accounts in FL, NV, OK, SC, and TX
The hazard
The recall involves the AnastoClip GC Closure System because the supplied instructions for use listed indications not cleared by the FDA. These uncleared indications include closure of arteriotomies and veinotomies, attachment of synthetic vascular prostheses, and approximation of dural tissue.
Context
GovInfoNow's records show LeMaitre Vascular, Inc. has had 13 other recalls since October 1, 2018. Recent recalls include a TufTex Catheter recall on August 28, 2026, due to balloon failure risk, and an Artegraft Vascular Graft recall on February 10, 2026, caused by a labeling mix-up. Other recent recalls of similar products include Medline ARTHROGRAM TRAY and TOL NEURO ANGIO PACK (February 25, 2026), Siemens SOMATOM X.ceed Software Applications Recall (December 19, 2025), and AVID Medical Halyard Arteriogram Recall (November 14, 2025).
How to tell if you have this one
Check for the product name 'AnastoClip GC Closure System' and reference number 4007-08. The device was sold for medical use in the United States.
Brand
LeMaitre Vascular
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number 4007-08 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed in 5 states.
Listed by the agency
Not listed
FDA distribution: “Distributed to accounts in FL, NV, OK, SC, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Nevada, Oklahoma, South Carolina, Texas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3042-2018 (June 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3042-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.