W L Gore & Associates, Inc. is recalling 52,306 GORE ACUSEAL Vascular Grafts due to reports of delamination, where the layers of the graft separate. This defect can lead to reduced blood flow, difficulties during medical procedures, bleeding, or bruising, and may require additional surgeries. The company is updating its Instructions for Use to clarify techniques that increase this risk and to add delamination as a known adverse event.
If the graft layers separate (delaminate), it can block blood flow through the device or cause complications during needle insertion. This failure could result in the need for unplanned medical interventions or reoperation to fix or replace the graft.
Used with Instructions for Use MD183888 Revision 4.
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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