FDA Classifies Previous Field Action of Medtronic Surgical Device as Class I Recall
November 1, 2010 – Last week, Medtronic Inc. announced that the FDA has classified the company’s previous action related to the Octopus® Nuvo Tissue Stabilizer as a Class I recall. In Sept. 2010, Medtronic recalled the device from the market due to the potential that a component of the device could fracture during use. The resulting potential hazards are that fragments of the component could fall into the patient’s chest cavity and/or damage the heart tissue.
Incidents / Injuries
Medtronic has received two reports of device failure occurring during patient use, which required retrieval of device fragments from the surgical wound. Healthcare facilities should immediately discontinue use of the device and return all unused Octopus Nuvo Tissue Stabilizer devices to Medtronic.
What is an FDA Class I recall?
The FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Do I have a Medtronic Recall Injury Lawsuit?
The Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Medtronic device recall lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Medtronic Octopus® Nuvo Tissue Stabilizer Lawsuit Evaluation: If you or a loved one has been injured by a defective Medtronic Octopus® Nuvo Tissue Stabilizer, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.