Ethicon Endo-Surgery is recalling approximately 27,092 units of ENDOPATH ECHELON 45mm Reloads with Gripping Surface Technology (GST) used in surgical procedures. The white vascular/thin reloads (Product No. GST45W) may fail to form a complete staple line or may fire without any staples at all. This defect can lead to serious complications such as internal bleeding or the need for additional surgery to fix the stapling issue. Affected units were distributed nationwide in the US and to Canada and Brazil.
An incomplete staple line fails to properly seal tissue or blood vessels during surgery, which can cause significant bleeding, prolonged operative time, or a delay in the surgical procedure while the surgeon addresses the failure.
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Sources: FDA iRES · Raw API Response
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