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.
LeMaitre Vascular is recalling its AnastoClip GC Closure System (REF# 4007-08) because the instructions for use include procedures not approved by the FDA. This could lead to unsafe medical procedures if used for unapproved purposes.
The device comes with instructions that list uses not approved by the FDA, such as closing arteriotomies and veinotomies. Using it for these purposes could cause complications or injuries since the device hasn't been cleared for those specific medical procedures.
Medical professionals who use the AnastoClip GC Closure System for surgical procedures may be affected. Patients undergoing procedures with this device could be at risk if the device is used for unapproved purposes.
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.
Look for the reference number 4007-08 on the device packaging or label.
The recall is due to instructions for use that list medical procedures not approved by the FDA, including closing arteriotomies and veinotomies.
The official recall notice does not mention any remedy or fix for this issue.
Check for the product name 'AnastoClip GC Closure System' and reference number 4007-08 on the device packaging or label.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-3042-2018 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-3042-2018 from LeMaitre Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
