Medical devices, like other mechanical tools and instruments, sometimes wear out. Just like when there is a problem with a part of your car, medical devices sometimes need upgrades or repairs. Both manufacturers and the U.S. Food and Drug Administration (FDA) issue an “alert” to alert doctors and patients of recalls and necessary remedies. But how do you know about these medical device recalls?

We spoke with Oliver Monfredi, MD, PhD, medical director of our heart rhythm device services at UVA Health, to learn more about medical device recalls and alerts. “Medical device warnings or recalls are fortunately rare, but not unheard of in the field of cardiac rhythm medicine,” Monfredi notes.

What is a “Medical Device”?

Medical devices help doctors and patients every day. They help contract diseases, monitor patients’ health, and support or replace the function of body parts. They can help keep you alive, reduce pain, help you sleep, or simply make your daily life easier.

Medical devices can be used outside or inside the body. They include devices such as:

And many, many more. Some are used for convenience, but others could help keep you alive.

What is a medical device recall or alert?

The term “recall” can be misleading, Monfredi explains, because the device is often not removed or returned to the manufacturer. Instead, we may need to make changes to the way your device is used or change how we monitor your condition.

If you or a family member is using a medical device that is subject to one of these advisories, there is no reason to panic. Many warnings are just precautions. They come out before problems appear in patients who use them. In fact, most patients who receive a device alert/recall will not encounter any type of problem and may simply be observed more closely. Monfredi says: “To be clear, while not perfect, the technology used in modern pacemakers and defibrillators is rigorously tested to the highest possible standards and recalls are extremely rare.”

Sometimes, only certain models or versions of a medical device are affected by an alert.

Types of decoys

It is important to pay attention so that if a recall is issued, you are aware of it and can take steps to ensure that you or a loved one has the safest and most effective version of that medical device.

Recalls vary in their level of severity. The FDA uses three classes:

• Class I is the most serious. There may be a risk of serious injury or death, such as when an internal defibrillator intended to return the heart to a normal rhythm malfunctions.
• Class II cases can result in injury, such as when packaging fails to keep something sterile.
• Class III is unlikely to cause injury, but there is a violation of FDA regulations, such as when a device’s dimensions are not accurately listed.

Why do medical device warnings or recalls occur?

Medical device recalls and warnings happen for a variety of reasons. Your device may be at risk of misbehaving, such as unexpected failure or providing incorrect information. Complications not encountered during the testing phase may occur.

Sometimes, the labeling or instructions seem clear when the device is first released. But they may prove confusing to patients or their families and need correction.

The software of some devices, such as heart rate monitors or insulin pumps, can also be the source of a problem. Software issues can compromise the security or performance of your device.

Actions taken by medical device manufacturers during a recall may include things like updating or clarifying instructions, fixing software bugs, or repairing or replacing the device.

How do I know if there is a warning or recall for my medical device?

To protect your privacy, patient names and contact information are generally not shared with medical device manufacturers. Therefore, these companies usually send recall notices directly to doctors and hospitals, who then inform their patients what is happening.

“We keep extremely detailed records of our patients and know all the hardware they have implanted. So if we are contacted by a device manufacturer regarding an alert or recall, we quickly create a list of affected patients and quickly communicate with these patients what the problem is and what, if any, will need to be done,” Monfredi says.

Sometimes you’ll see stories in the media about a recall. Websites dedicated to certain diseases and medical conditions also often publish this information.

But if you have a medical device that helps you stay healthy, you don’t want to miss out on news on an alert. There are things you can do to stay current.

What can I do to stay informed?

#1: Keep records

First, it’s important to know the make, name, model, and serial number of your device, as not all versions are always included in a recall. Check the documentation that came with your device, write down the information, and keep it in a handy place. If your device is part of an alert, this will help you know if your version is included.

#2 Sign up for alerts

Second, you can register on the FDA website to receive alerts about device recalls.

Added bonus: You can also sign up for FDA MedWatch alerts on prescription and over-the-counter drugs, foods and food ingredients, vaccines, cosmetics, pet foods, livestock feed, and medical devices (and more).

#3 Browse the database

Third, you can search the FDA’s medical device recall database, which contains information on years of device recalls.

#4 Register with your device manufacturer

You may be able to register with your device manufacturer. This opens a direct line of communication to receive recall information directly from the manufacturer. Alerts are targeted exactly to the device model you have. This reduces confusion and the need to do detective work to see if your device is affected.

#5 Stay in touch with your doctor

Finally, make sure your doctor and pharmacist have your current contact information. This way they can contact you quickly if they need to inform you of any device recalls.

What should I do if my device is recalled?

If you learn that your device is part of a warning, do not stop using it until you talk to your doctor, unless the recall notice specifically tells you to stop using it. In these cases, make absolutely sure that the exact model(s) of the recalled device matches yours. Stopping alone could put your health at risk. Your doctor can discuss your options when the recall notice doesn’t tell you to stop using the device immediately.

“We are always happy to be contacted by any heart rhythm device patient with concerns about how their device is working and whether it is, or has ever been, subject to advice or recall. We are here for you if you have any questions or concerns,” says Monfredi.

In short, stay informed, keep good records, and make sure your healthcare providers have your current contact information. Talk to your doctor if you have questions. These steps will help safeguard your health and that of any loved ones who may use medical devices.