LeMaitre Vascular, Inc. is recalling 10 units of Artegraft Collagen Vascular Grafts because they were distributed with incorrect labels and missing essential patient documentation. The affected devices are missing the required CE and UKCA marks, as well as the patient leaflet and patient implant card. These medical devices are used as substitutes for blood vessels in patients who need arterial bypass surgery or hemodialysis access.
Missing patient documentation and incorrect labeling could result in a lack of critical safety and usage information for both healthcare providers and patients. While no injuries have been reported, proper labeling and documentation are essential for ensuring the safe and compliant use of medical implants.
Missing CE/UKCA mark and patient documentation.
Missing CE/UKCA mark and patient documentation.
Missing CE/UKCA mark and patient documentation.
Missing CE/UKCA mark and patient documentation.
Missing CE/UKCA mark and patient documentation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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