LeMaitre Vascular, Inc. is recalling 28 units of Artegraft Collagen Vascular Grafts because the bovine (cow) carotid arteries used to manufacture these specific lots were sourced from a supplier that was not reviewed or approved by regulatory authorities. The recall affects 15 different model types of the collagen vascular grafts. Healthcare providers should immediately check their inventory for the impacted units to prevent use in surgical procedures.
Because the raw bovine material was sourced from an unapproved supplier, the manufacturer cannot guarantee the safety, sterility, or long-term performance of the grafts. Using a graft with unverified quality standards could potentially lead to device failure, infection, or other complications for the patient.
Quantity affected is 28 units across various model and serial numbers.
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.
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Sources: FDA iRES · Raw API Response
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