The U.S. Food and Drug Administration (FDA) classified Vycor Medical, Inc.’s decision to recall its ViewSite Brain Access System as a Class I recall, the most serious kind.
What Is the ViewSite Brain Access System?
In brain and spinal operations, surgeons need to separate away tissues covering target areas with great care. Typically they use “blade retractors,” which are metal tools with bent edges surgeons can place in incisions and pull away various tissues. Vycor’s ViewSite Brain Access System is essentially a hollow tube that’s placed inside the incision, which allows surgeons to use multiple tools more freely and safely than with blade retractors.
ViewSite Brain Access System Might Cause Life-Threatening Side Effects
On August 21, 2012, Vycor contacted the purchasers of ViewSite Brain Access Systems distributed between June 8, 2012, and July 9, 2012, because it found an unidentified black fiber on the devices. The affected products are Model No. TC171105, Lot No. VM83450. Vycor recommends owners place their units in quarantine and contact Vycor. On January 30, 2013, the FDA classified Vycor’s action as a Class I recall because there is a reasonable probability that the device can cause serious injury or death if used in patients.
RLG’s ViewSite Brain Access System Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a ViewSite Brain Access System lawsuit on your behalf if necessary. RLG will also keep you up to date on any ViewSite Brain Access System class action lawsuits, FDA ViewSite Brain Access System warnings, and additional ViewSite Brain Access System FDA recall announcements. If you or a loved one underwent a surgical procedure involving a ViewSite Brain Access System and believe it caused an injury, contact RLG today.