Aesculap Implant Systems LLC is recalling 25 units of their Trocar surgical devices, model FF399R, designed for operations within the brain ventricles. These devices were manufactured with a shaft that is too long, which does not meet safety and manufacturing specifications. When used with a 30-degree neuroendoscope during surgery, the excess length can block part of the surgeon's view, creating a significant safety hazard during delicate brain procedures. The affected units were distributed across nine states including Florida, Idaho, Illinois, Maryland, North Carolina, New York, Oregon, Rhode Island, and Texas.
The overly long shaft can obscure the surgical visual field when used with specialized endoscopes. This loss of visibility during neurosurgery can lead to surgical errors, unintended tissue damage, or incomplete procedures within the brain ventricles.
Manufacturer notification and corrective action
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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