A Class 1 recall by the Food and Drug Administration is nothing to take lightly. The FDA only uses this classification when serious injury or death is likely to occur. In May 2009, certain Medtronic pacemakers were recalled due to a high risk of failure caused by the separation of wires in the device. This was a Class 1 recall that has affected thousands of people. Are you a victim?
As you know, patients who rely on a pacemaker need their device to work flawlessly. Any failure can lead to serious injury or even death.
It is believed that there are roughly 1.7 million Medtronic pacemakers implanted in patients. Fortunately, it is also believed that only 21,000 of the units are affected by the Class 1 recall. Most of the flawed devices have been in patients for at least five years.
Medtronic has taken the initiative in alerting doctors who have used these devices in patients. Additionally, they also sent letters to patients to keep them abreast on the situation and what they should do to ensure their safety.
The Medtronic pacemakers affected by the recall are the Sigma Series 100/200/300 and the Kappa series 600/700/900.
If you think you have one of these pacemakers you should immediately contact your physician. It is important to address this problem as soon as possible as it has the potential to lead to serious injury or death.
If you have been implanted with a Medtronic pacemaker that has been recalled do not hesitate to contact the lawyers at The Law Offices of Richard J. Serpe, P.C. for a free consultation.