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Heart disease, also known as cardiovascular disease, can have serious consequences. Medical devices approved by the U.S. Food and Drug Administration, such as pacemakers and defibrillators, the leading cause of death among adults in the United States, have extended and improved the lives of millions of people living with heart disease.

The FDA evaluates the safety and effectiveness of certain devices before they are sold to the public, including devices used to treat cardiovascular disease and other related problems. Many of these FDA-approved medical devices can be implanted inside the body, while others are used outside the body. Healthcare providers decide which cardiovascular device is best for each patient.

Below are several categories of FDA-approved devices used to treat various cardiovascular problems. Types of cardiac devices include:

Automated external defibrillator: These handheld automated devices, commonly referred to as AEDs, are often located in public places and can save lives. They help restore normal heart rhythm in patients whose heart suddenly and unexpectedly stops pumping blood, a phenomenon called cardiac arrest. An AED analyzes heart rhythm and helps rescuers determine whether a shock is needed to restore a normal heartbeat. Although these devices are not difficult to use, training in the use of an AED is highly recommended. For more information about AEDs, visit the FDA website.

Cardiac ablation catheter: A cardiac ablation catheter is a long, thin, flexible tube inserted into or over the heart to treat abnormally fast heartbeats. They work by correcting small areas of heart tissue that are causing abnormal heart rhythms.

Cardio angioplasty device: These are long, thin, flexible tubes that are screwed into the heart and other blood vessels to widen narrowed or blocked areas. These are intended to improve blood flow to the heart, reduce chest pain, and treat heart attacks.

cardiac pacemaker: Small, battery-powered pacemakers are implanted inside the body. Used when the heart is beating too slowly, it monitors the electrical impulses in the organ and delivers electrical stimulation as needed to make the heart beat at a more appropriate rate.

Implantable defibrillator: These devices monitor the heart’s rhythm and deliver a shock at a steady heart rate if a dangerously fast rhythm is detected. Many record the heart’s electrical patterns when certain abnormal rhythms occur, allowing doctors to see the patterns.

Artificial (artificial) heart valve: Used to replace diseased or malfunctioning heart valves that direct blood flow within the heart, these are available in two forms. Mechanical valves are made of man-made materials. The second type, called a bioprosthetic valve, is made from tissue taken from an animal or human cadaver.

Stent: A stent is a small lattice-like metal tube that is permanently inserted into an artery to improve blood flow. Some contain drugs that may reduce the chance that the artery will become blocked again.

Ventricular assist device: VADs are mechanical pumps intended to help weakened hearts pump blood effectively and were originally approved for short-term use until a donor heart becomes available. Some are currently approved for long-term treatment of patients with severe heart failure who are not candidates for heart transplants.

When to seek medical help

If you have any questions or concerns about your heart, please consult your doctor. If you feel you are having a heart attack or other medical emergency, call 911 immediately.

Know the warning signs and symptoms of a heart attack. The chance of survival is higher if emergency treatment is started immediately.

Sudden cardiac arrest occurs when the heart suddenly and unexpectedly stops pumping blood. If cardiac arrest occurs, prompt treatment with a life-saving AED is essential. Defibrillation is a time-sensitive process, and for every minute the heart is in cardiac arrest, the chance of survival decreases by 7% to 10%.

First responders are typically equipped with and trained to use an AED. These devices are also commonly seen in public places, and people trained in CPR or AEDs can use them to help someone in cardiac arrest.

Report device issues to FDA

If you believe that you or someone you know has had a problem with your device or experienced a side effect related to the use of your device, please report the problem through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

If you have any questions about your AED device or AED accessory, please contact the manufacturer. You can also call the FDA Consumer Complaint Coordinator who works with your state. Phone numbers are posted online.

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