Tuesday, June 18, 2024

Medical Devices Recall: FDA Issues Class I Warning for Medtronic StealthStation S8 Software Errors

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The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall, indicating that the use of these medical devices may cause serious injuries or death. Medtronic is recalling certain versions of the StealthStation S8 Application due to software errors. This medical devices recall affects 876 devices distributed in the U.S. from March 21, 2017, to March 22, 2024. The recall was initiated on April 10, 2024, to address potential risks and ensure patient safety.

The affected product is the StealthStation S8 Application, used during neurosurgery to locate anatomical structures. The recalled versions include 1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1. This system aids in various cranial procedures, including tumor resections, ventricular catheter placements, depth electrode placements, and cranial biopsies. The software error causing the recall involves missing numbers or letters in the “distance to target” or “tip stop point” display, potentially leading to incorrect placement of surgical instruments. These errors could severely impact surgical outcomes.

Urgent Recall of Medtronic StealthStation S8 Medical Devices Due to Serious Software Malfunctions

The software malfunction could result in the mechanical depth stop being set incorrectly, causing serious permanent injuries. These injuries could include brain, nerve, or cerebrovascular damage, abnormal functions to the brain, spine, or muscles, paralysis, or even death. Despite 28 reported complaints, there have been no reported injuries or deaths related to this issue. However, the potential for harm remains significant, necessitating this urgent recall.

Those affected include patients undergoing cranial surgery with the StealthStation S8 and surgeons using the affected software versions. Medtronic issued an Urgent Medical Device Correction letter on April 10, 2024. The letter outlines actions for customers, including reviewing the correction information with all physician users, completing and returning a confirmation form, and maintaining a copy of the notice in facility records. These steps are essential to ensure that all users are informed and corrective measures are implemented promptly.

Medical Devices

Medtronic Issues Free Software Update to Resolve StealthStation S8 Medical Devices Error

Medtronic will coordinate a software update at no charge to resolve the error. Customers are instructed to pass the notice on to relevant parties within their organization and to any other organizations where the affected medical devices may have been transferred. This prompt action is crucial to ensure patient safety and mitigate risks associated with the recalled devices. Implementing these updates will help prevent potential injuries and enhance the safety of neurosurgical procedures.

Medtronic’s proactive approach in addressing this issue underscores the importance of vigilance and rapid response in the medical devices industry. By promptly notifying users and coordinating necessary updates, Medtronic aims to minimize risks and maintain the integrity of its products. This medical devices recall serves as a reminder of the critical role that accurate and reliable medical software plays in patient safety and surgical success.

The collaboration between Medtronic, the FDA, and healthcare professionals highlights the importance of transparency and communication in managing medical devices recalls. By working together, these stakeholders can address issues swiftly, protect patient health, and uphold high standards of medical care. This coordinated effort reinforces the commitment to safety and quality in the healthcare industry.


Resource: Food and Drug Administration, June 06, 2024

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