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.