LeMaitre Vascular recalls Artegraft Collagen Vascular Grafts with model numbers AG 616-1030 due to unapproved raw material from supplier. Affected items may pose health risks if used in medical procedures.
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts with specific model numbers because the raw materials used in production were sourced from a supplier not approved by regulatory authorities. This could lead to health risks if the grafts are used in medical procedures.
The grafts were made using bovine carotid arteries from a supplier that did not have regulatory approval. This means the materials might not meet safety standards, potentially causing complications during medical procedures.
Medical professionals who use these grafts for vascular procedures are most at risk. Patients receiving these grafts during surgery may be affected if the grafts are used without proper regulatory approval.
Check for model numbers AG 616 through AG 1030 on the grafts. Also look for the UDI-DIs starting with 00316837000213 and serial numbers beginning with 23DD203 or 23KK498.
Identify the model number, UDI-DI, and serial number on the graft to confirm if it is affected.
The raw materials used in production were sourced from a supplier not approved by regulatory authorities, which could pose health risks during medical procedures.
Model numbers AG 616 through AG 1030 are affected, as listed in the recall notice.
Check the model number, UDI-DI (starting with 00316837000213), and serial number (beginning with 23DD203 or 23KK498) on the graft.
We’ve drafted a message you can send LeMaitre Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-0034-2026 — LeMaitre Vascular LeMaitre Vascular Hello, I own a LeMaitre Vascular that is covered by recall Z-0034-2026 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.
