Stealth Station S7 Cranial Software FDA Class I Recall

Significant advancements in the field of neurosurgery – procedures wherein a patient’s skull is actually opened up and the brain is operated on – have made these sensitive and delicate operations safer than ever. This assumes, of course, that the software and technology that makes these procedures possible function as designed and anticipated. Imaging software from Medtronic, specifically the Stealth Station S7 Cranial Software, has recently been the subject of a Class I recall from the Food and Drug Administration (FDA) over dangers that use of the software can threaten the safety of patients.

What is a Class I Recall?

If the FDA receives credible information that a product that falls under its regulatory powers poses a danger to humans, the FDA may issue a recall. The purpose of a recall notice is to alert consumers and others who may utilize the affected product of the dangers the product poses and what steps they need to take in order to protect themselves and others from harm. The recall affecting the Stealth Station S7 Cranial Software is classified as a Class I recall. This means that the dangers posed by the Stealth Station S7 Cranial Software present a risk of serious injury or death to patients whose neurosurgical procedures involve the use of such software.

How is the Stealth Station S7 Cranial Software Utilized?

Medtronic’s Stealth Station S7 Cranial Software is a 3-D imaging software that is supposed to provide neurosurgeons a precise image of a patient’s brain during a surgical procedure, including the location of surgical instruments that have been inserted into the brain as part of the procedure. This software is supposed to give neurosurgeons pinpoint accuracy, enabling them to operate on injured parts of the brain without damaging the surrounding tissue.

A defect in the Stealth Station S7 Cranial Software, however, allegedly results in the surgeon being presented with an image of the patient’s brain that is not accurate. More specifically, the image provided to the neurosurgeon does may not accurately show where instruments the surgeon is using during the procedure are located. The neurosurgeon may force or insert an instrument too far into an area of the brain, or may insert an instrument into the wrong area of the brain, which can be devastating to the patient. A patient may suffer a coma or stroke, or his or her functioning affected temporarily or permanently. In serious cases, the patient may die from a blood clot, stroke, or infection of the brain.

How Can Patients Protect Themselves from Stealth Station S7 Cranial Software Injuries?

Medtronic, the manufacturer of Stealth Station S7 Cranial Software, has informed neurosurgeons and others who use the software of steps they must take in order to reduce the risk of errors and mistakes occurring from use of the cranial software. If you or a loved one are expecting to undergo a neurosurgery, it is extremely important that you speak with the surgeon to determine if he or she utilizes the Stealth Station S7 Cranial Software and, if so, whether the surgeon is aware of the steps he or she needs to take in order to use the software safely (as recently set forth by Medtronic). You may also wish to see if the surgeon is able to use other software, or you may be interested in attempting to locate another surgeon who does not use Medtronic’s potentially defective software.

Speak with an Experienced Medtronic Defective Software Attorney Today

If you or a loved one have reason to suspect that you were injured in a neurosurgical procedure because of defective Medtronic cranial software, Parker Waichman LLP would like to speak with you about your rights in a free, no-obligation case consultation. Call 1-800-YOURLAWYER (1-800-968-7529) and speak with a member of our legal team about your rights to compensation.

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