Heart Device and Pacemaker Recalls: What You Need to Know
The FDA sometimes recalls pacemakers or other implanted heart devices. It may sound frightening, but the risk is very small. A cardiologist highlights what you need to know.
Do you have a pacemaker or other electrical heart device? At some point, you may hear of a recall because of a possible problem. Keep in mind that even though it’s a frightening prospect, it’s not likely to be urgent.
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“Remember that the problem is not an emergency when you’re just learning of it today,” says cardiologist Bruce Wilkoff, MD, Director of Cardiac Pacing and Tachyarrhythmia Devices at Cleveland Clinic. “Most of the time, the risk is very small, and we do nothing except watch the device more closely.”
The Food and Drug Administration (FDA) must approve pacemakers, implantable cardioverter-defibrillators (ICDs), implantable loop recorders (ILRs), and the leads or wires that connect to your heart. They all have to meet safety standards before they go to market.
But, like any product, implanted electrical devices don’t last forever. And potential problems may arise.
Your doctor must notify you if there’s a potential problem. He or she will try to do so as quickly as possible — typically with a phone call or letter. But sometimes, you may hear manufacturer or media reports on an FDA recall first.
“If that happens, don’t panic. Call your doctor and talk it through,” Dr. Wilkoff says.
Your doctor will outline a course of action, tailoring it to fit your needs.
“We look at the type of device and the type of patient and come up with a specific plan for that particular situation and patient,” Dr. Wilkoff says. “We want to make sure the solution is not worse than the problem.”
For instance, if you are less dependent on your pacemaker, your doctor may ask you to follow instructions as usual. You’ll likely need an office visit only if you notice any changes, such as unusual fatigue or lightheadedness.
Or, your doctor may advise you to schedule an appointment so that your doctor can use a software program to adjust your device.
“Sometimes it requires us to remove and replace a device. But that is quite uncommon for pacemakers and defibrillators,” Dr. Wilkoff says.
Whatever the recommendation, remember that your doctor understands the anxiety and uncertainty a recall letter can create — even if the letter doesn’t call for any action.
“If you’re still concerned, call anyway,” he says. “We’re here to help you. The decision is best made as a shared decision between the doctor and patient.”