Acclarent, Inc. is recalling 141 TruDi Navigation Systems (Model FG-2000-00) when used specifically with TruDi Curettes (Models TDC0005Z and TDC0005) running software versions 2.3.1.144 or 2.3.1.166. A software defect causes the system to display the surgical tool in the wrong location on the screen compared to where it is actually positioned inside the patient. This discrepancy can lead to serious surgical errors during Ear, Nose, and Throat (ENT) or skull base procedures. Consumers should contact their healthcare provider or the manufacturer for instructions on how to handle affected devices.
The software error creates a gap between the tool's actual position and its digital representation, which may cause surgeons to inadvertently damage critical structures. This poses a risk of cerebrospinal fluid leaks, permanent visual impairment, or structural damage to the skull base.
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.
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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