Dangerous Medical Device Recall: The TruDi Navigation System Defect

Medical technology is marketed to patients as tools to help improve patient safety and outcomes, but when it fails, the consequences can be devastating. 

One recent example is the recall of the TruDi Navigation System, a device used to guide surgical tools during delicate procedures. This recall has raised serious concerns for patients and families affected by unexpected complications after treatments using the defective device.

If you or a loved one experienced adverse health effects after receiving treatment with a TruDi Navigation System, contact Morgan & Morgan, America’s largest personal injury law firm, for a free case evaluation to learn more about your legal options. You may be entitled to compensation for your injuries, medical bills, and more.

What Is the TruDi Navigation System Recall?

The TruDi Navigation System is a surgical navigation tool developed by Acclarent, Inc. designed to help surgeons visualize the position of instruments during complex ear, nose, and throat (ENT) and skull base procedures. A software defect in this system, however, has caused inaccurate displays of tool locations.

In October 2025, the U.S. Food and Drug Administration (FDA) issued a Class 2 recall (Z-0127-2024) for this device due to a risk that it may not meet specified accuracy requirements when certain revisions of components are used together. Devices with the affected software may display incorrect guidance information to surgeons.

Unlike the most serious recalls, a Class 2 recall indicates the defect may cause temporary or reversible health problems, but it still represents a significant risk during surgical procedures where precision is critical.

Why the TruDi Recall Matters to Patients

For many ENT or skull base surgeries, accurate navigation is essential. When visualization software is incorrect, tools may be misdirected, increasing the risk of serious injury. Some complications linked to the TruDi system include:

• Cerebrospinal fluid (CSF) leaks, a condition that can be life-threatening if left untreated.
• Skull base damage, where delicate structures around the brain are compromised.
• Carotid artery dissection, which can lead to stroke or long-term neurological impairment.
• Visual impairment or ocular nerve damage, potentially causing partial or permanent vision loss.
• Additional surgeries or prolonged hospital stays, both physically and financially burdensome for patients and families.

These outcomes illustrate just how serious surgical navigation errors can be — even when a recall is labeled Class 2 by the FDA.

Who May Be Affected by the TruDi Recall?

Devices covered by this recall were distributed broadly across the United States, including hospitals in states like California, New York, Texas, Florida, and others. Patients who underwent ENT or skull base surgery involving the TruDi system, especially where unexpected complications occurred, may have been impacted.

Some injuries may not appear immediately, and complications that seem unrelated to the original surgery could eventually be linked to the device’s malfunction. For example, strokes and other vascular injuries are being reported in recent news accounts related to these surgeries.

Should I Take Legal Action for the TruDi Recall?

If you or a loved one experienced unexpected medical issues after a procedure where the TruDi Navigation System was used, it’s important to explore your options. You may be eligible to pursue compensation if you experienced:

• Unanticipated postoperative complications such as extensive recovery times, neurological symptoms, or additional corrective procedures.
• Medical expenses or lost wages due to extended care.
• Long-term disability or diminished quality of life following surgery.
• Emotional suffering tied to injury or prolonged recovery.

Experienced defective medical device attorneys can review your case to determine whether the device’s malfunction contributed to your injuries. Because every state has time limits for filing claims, known as statutes of limitations, acting promptly is important to protect your legal rights.

Has Your Medical Care Caused More Harm Than Good? Morgan & Morgan Can Help

Medical device litigation is complex. Morgan & Morgan’s specialized lawyers with deep experience in FDA recalls and product liability can help by identifying whether your complications are linked to the recalled device and by gathering and preserving medical records and surgical data.

Our compassionate legal team can work with medical and technical experts to build a strong personal injury case, pursuing damages for past and future medical care, lost income, pain and suffering, and more.

For over 35 years, Morgan & Morgan has fought For the People, holding manufacturers accountable to encourage safer medical technologies and to recover the compensation victims need and deserve to move forward with their lives.

If you believe you’ve been harmed by the TruDi Navigation System, you don’t have to face the aftermath alone. Legal support is available to help you seek justice and financial recovery

Hiring one of our lawyers is easy, and you can get started in minutes with a free case evaluation.