The FDA has classified the recall as the agency believes that the use of the product will cause serious adverse health consequences or death.

Reportedly, on 14 September 2010, Medtronic proactively and voluntarily 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.

Medtronic has received two reports of device failure occurring during patient use, which required retrieval of device fragments from the surgical wound and neither event resulted in permanent impairment or death.