Probably nothing is more frightening than finding out that one of your medical devices has been recalled. This is especially true if the device is inside your body, such as an artificial hip, pacemaker, etc.
Before you panic, however, the Food and Drug Administration advises that a recall can mean one of three things as follows:
- The device itself is defective.
- It could pose a health risk for you.
- It is defective and its defect poses a health risk.
Recalls come in two kinds: correction recalls and removal recalls. Both the FDA and the device’s manufacturer have the authority to initiate either kind.
If your doctor notifies you that your medical device has become subject to a correction recall, this is not terribly serious. It simply means that you should make an appointment with him or her so (s)he can check the device and make sure it is still working the way it should be. For instance, if you have a pacemaker, its battery may need recharging or replacement.
Removal recalls are more serious. Here the FDA has determined that the device is inherently dangerous and poses a significant health risk. The manufacturer then notifies all the physicians who used the device. Your doctor, in turn, will notify you that you need to make an appointment with him or her as soon as possible so (s)he can explain the situation to you. (S)he will also tell you about the risks involved in surgery to remove and replace the recalled device as opposed to your health risks if you decide to leave it in place and continue to let him or her closely monitor its performance.