Topic Overview

What is a recall?

Medical devices are recalled when they have a problem that needs to be fixed or watched closely. The device may not work right, may be a health risk, or both.

A cardiac device—such as an implantable cardioverter defibrillator (ICD), a pacemaker, or the leads that connect them—helps your heart beat steadily. If a cardiac device were to fail, it might not provide a shock when needed or keep your heart beating at a steady rhythm. But it’s rare for cardiac devices to fail or be recalled.

A recall is usually issued by the maker of the device. But the U.S. Food and Drug Administration (FDA) also can recall devices.

Does your device need to be removed if it’s recalled?

A recall of a cardiac device does not mean that it needs to be removed. In most recalls, devices are watched closely or reprogrammed. Only a small number are removed.

The FDA has three levels—or classes—of recall, depending on the chance of a device failing and possibly hurting someone.^{footnote 1}

• Class I: This is the most serious type of recall. A device has a high risk of causing harm or death.
• Class II: The device has some chance of having a serious problem. But most problems may be short-term and can be fixed.
• Class III: The device has a low risk of causing a health problem.

The decision to remove the device depends on how likely it is that the device might fail or cause harm. Your doctor will consider which is more likely to happen: problems from surgery to replace the device, or the device failing.

What would happen if your cardiac device were recalled?

The maker of the device would contact you if your device were recalled. Your doctor also might contact you.

You would meet with your doctor to talk about the problem and what to do. In most cases, your doctor would check the device often to make sure it’s working right. Your doctor might need to reprogram the device.

If you read or hear about a recall and you’re curious to know whether your device is affected, you can check the information on your device ID card. To be part of a recall, your device must match the recalled device in ALL of these areas:

• The company that made the device. If, for example, your ICD was made by a different company than that in the recall, your device isn’t part of the recall.
• The type of product. What is being recalled—a pacemaker or an ICD? If an ICD is being recalled and you have a pacemaker, you are not affected by the recall.
• The model and serial number. These numbers are on the device ID card.
• The date the device was made or implanted. The maker of the device lists a time period when the device was made or implanted. Your device must match this time period to be part of a recall.

Call your doctor if:

• Your device is part of a recall and you haven’t been contacted already.
• You’re not sure if your device is part of a recall.