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What Should I Do If I Have an Implanted Recalled Medical Device?

Manufacturers and the FDA issue countless recalls annually for hazardous drugs, food and beverages, and medical devices. On average, about 4,500 drugs and devices are pulled from U.S. shelves each year. Many of these recalls come after consumers have used the products in question for months or even years. In 2021, the FDA reported 57 medical device recalls, all of varying degrees. However, sometimes patients are left wondering what to do if they currently have a recalled medical device implanted. Continue reading to learn more about what to look for and advice if you have a recalled medical device in your body.

Why Might a Manufacturer Recall an Implanted Medical Device?

Manufacturers or the FDA can recall a medical device for any number of reasons. Although a recall may sound like an urgent matter, sometimes it originates from a minor incorrect label or packaging defect. The FDA believes products in its Class III category are unlikely to cause adverse health consequences. While it is still a recall, it is often for a minor violation. For example, an organic product labeled as inorganic may fall under a Class III recall. 

However, several recalls have involved medical devices that present a risk of injury or death for users. The FDA typically classifies these cases as Class 1 or Class II recalls. With a Class II recall, a medical device may cause a temporary or reversible health problem. Also, with a Class II device, there is a slight chance that it will cause serious health problems or death. For instance, the FDA placed Exactech’s recalled knee and ankle implants in Class II. Exactech recalled these devices due to reports of higher failure and revision rates. On the other hand, a Class I is a situation where there is a reasonable chance that a product will cause serious health problems or death. The FDA identified Medtronic’s recall of its MiniMed Insulin Pumps as a Class I recall. 

It is important to know how the FDA categorizes your implanted recalled medical device. A Class I recalled medical device may pose a severe threat to your well-being, but a Class III recalled medical device can be inconsequential. This information will determine your risk level and what your next steps should be. 

How Do I Know if My Implanted Medical Device Has Been Recalled?

A manufacturer will investigate safety reports concerning malfunction, injuries, and deaths related to its medical device. Based on this information, a manufacturer may launch a recall. When a manufacturer issues a voluntary recall, it will inform the FDA. The agency will then notify the public through its website with details and assign its classification. 

Yet, there is a delay before patients will learn of a medical device recall. The device manufacturers mail letters to hospitals and healthcare providers to alert them of the recalled medical devices. As you can imagine, these letters take time to reach their destination or may get lost in transit. Sometimes hospitals may not know about a recalled device for weeks or even months. Once healthcare providers and hospitals are aware of the recall, they advise patients with the recalled implanted medical devices. Unless the manufacturer distributes the device directly to patients, it usually does not inform patients themselves. 

You can also be proactive in tracking your implanted medical device. Searching your implanted medical device online or in the FDA database can help you find updates on recalled medical devices. 

How Can Recalled Medical Devices Injure Patients?

A recalled medical device may cause adverse health events. The device, function, placement, and reason for its recall factor into what patients may experience. Patients with implanted recalled medical devices have reported: 

• Revision surgery 
• Chronic pain
• Internal bleeding 
• Bone loss 
• Mobility issues 
• Organ damage
• Infections 
• Stroke 
• Sepsis 
• Neurological dysfunctions 
• Death 

These are just some examples linked to recalled implanted medical devices. There is no guarantee that you may experience any of these complications. 

Speak With Your Doctor

While it is frightening to learn that you have a recalled medical device inside of you, you should not jump to conclusions. You might think you must remove your device as soon as possible, but this is not always the case. First and foremost, you need to consult your doctor. A healthcare provider will have a greater understanding of how the recalled implanted medical device may impact your health. Furthermore, you must be completely transparent and detailed. If you are experiencing any pain or odd symptoms out of the ordinary, ensure you express this to your doctor.