Covidien, LP is recalling approximately 3,053 units of Signia Small Diameter Curved Tip Intelligent Reloads (Model SIGSDS30CTVT). Under certain conditions, these surgical reloads can move in an uncontrolled manner during use, which may disrupt the staple line during medical procedures. This issue occurs because internal components in the reloads are not fully secured, impacting both the Endo GIA Ultra Universal Stapler and the Signia Stapling System. Consumers and healthcare providers should contact the manufacturer immediately for guidance on handling these specific reloads.
The internal components of the reload are not fully secure, causing the device to move or articulate unexpectedly during a procedure. This uncontrolled movement can lead to an incomplete or disrupted staple line, potentially causing surgical complications or injuries to the patient.
Manufacturer Notification
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.
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Sources: FDA iRES · Raw API Response
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