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What should I do if my pacemaker has been recalled?

The best way to begin answering your question is to first talk about what happens when a defective medical device is recalled. This approach may actually provide you with the answers you seek.

There are many reasons manufacturers or the Food and Drug Administration (FDA) may recall a medical device. However, it is safe to say that most times a medical device recall happens because of a defect. Sometimes, this defect may be a threat to the patient's health or life while other times, the defect may simply involve the way the device works.

In pacemakers and other medical devices, there are three classes of recalls. These are:

  • Class I: By far the most serious, this class of recall means the device has a high risk of causing death or injury.
  • Class II: This classification usually means that the device has a serious problem, but can be repaired or made to work properly.
  • Class III: If the recall is given this classification, you can rest assured that the device has a very low chance of leading to a health problem.

Regarding the question, in most recalls, patients receive a notification about the defective medical device recall and given instructions on what to do. This typically means meeting with your physician to talk about what action, if any, is needed.

If you have not received a notification but you know your device is included in the recall, contact your doctor right away. You should also contact your physician if you are not sure whether your pacemaker is part of a recall.

It is also wise to speak with an Illinois based lawyer about your defective medical device. Taking this advance step helps you prepare for the possibility of filing a products liability lawsuit against the device's manufacturer.

Source: WebMD, "What to Do if Your Cardiac Device Is Recalled," accessed Sep. 29, 2017

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