Brainlab Issues Class 1 Recall for Navigation System

Brainlab Issues Class 1 Recall for Navigation System Surgeons frequently use specialized medical devices to assist them. Precision is an absolute requirement, since even the tiniest error can lead to serious injury or death. For example, Brainlab, a maker of medical navigational systems recently issued a Class I recall on January 15, 2016. A Class I recall is the most serious one identified by the Food and Drug Administration (FDA), because the defect can result in serious injury or death.

The Brainlab Cranial IGS System was created to assist with minimally invasive procedures with the goal of improving surgical outcomes. It uses a navigation-type system to show the position of a medical instrument in relation to a specific part of the patient’s anatomy. However, this system is being recalled due to possible inaccuracies in the display. These inaccuracies can cause a surgeon to operate on the wrong area, or perhaps hit a major nerve.

This recall affects the Brainlab Cranial IGS System and Brainlab Cranial Navigation Systems, distributed between May 1996 and May 2015. The recall affects all existing versions, prior to Cranial 3.0.

Customers were first notified of this issue in April 2013, with an update issued in May 2015. Surgeons and other affected medical staff can still use the affected products, but should familiarize themselves with the supplemental document entitled “Measures to Improve Cranial Navigation Accuracy”. This document contains information that can help healthcare providers improve the system’s efficiency, reducing the incidence of error.

In the U.S., 1,021 units of the Brainlab Cranial IGS System and Brainlab Cranial Navigation Systems are being recalled in the United States. The affected products were distributed in eight states: California, Texas, Maryland, Ohio, Pennsylvania, Colorado, North Carolina and Arkansas.

There is no need to discard or return the devices or even discontinue their use. Providers will receive updated software from Brainlab, and can schedule an installation update. Customers with any inquiries about the recall can contact Brainlab via email at, or they can call the company’s customer hotline at 1-800-597-5911. Medical providers who need to report a problem or adverse event should contact the FDA as soon as possible.

The Brainlab Cranial IGS SystemSurgeries always carry the risk of serious side effects or injuries. A patient’s safety is of utmost importance. Unfortunately, many manufacturers deny any wrongdoing and even go to great lengths to hide any potential risks, especially ones that are serious in nature. It’s commendable that Brainlab issued the recall and is working with the FDA to resolve this issue.

It is unclear if any adverse events have been reported, in conjunction with this recall. It is hopeful that Brainlab was able to alert surgeons and other hospital staff, before any patients were affected by the device defect.

It is important to understand that patients injured by defective medical devices do have legal rights. Nadrich & Cohen’s defective medical device team has helped victims & their families recover compensation for medical expenses, lost wages, pain and suffering, and other damages. If you believe that you or a loved one was injured during a procedure where the Brainlab navigational system was used, call us at 1-800-718-4658 for a free consultation.