Medical Device Recalls: What Patients Need to Know
A medical device is supposed to help you heal, manage a condition or improve your quality of life. But when something goes wrong, the consequences can be serious.
Medical device recalls are one way the FDA and manufacturers alert the public to problems that could put patients at risk. While recalls happen regularly, a recent analysis of the FDA's database revealed a surprising finding: a relatively small number of major manufacturers account for more than half of all medical device recalls.
Who Has the Most Recalls?
According to the analysis, the 50 manufacturers with the most recall records account for about 52% of all recalls, even though they represent only about 1% of the companies appearing in the FDA database.
The manufacturers with the most recalls include some of the biggest names in medical technology, such as Zimmer Biomet, Philips, Stryker, Siemens Healthineers and Medtronic. These companies make a wide variety of products used throughout the healthcare system, including:
- Orthopedic devices, such as joint replacements and other implants
- Medical imaging equipment, including CT and MRI systems
- Heart and vascular devices
- Infusion and drug-delivery equipment
Most Recalls Are Class II
Not all recalls carry the same level of risk. The FDA classifies medical device recalls according to the potential danger to patients.
The analysis found that approximately 88% of recalls were Class II. These involve devices that could cause temporary or medically reversible health problems, or where the risk of serious harm is considered relatively low. Only about 9% were Class I recalls, the most serious category. Class I recalls involve products that could cause serious injury or death.
The classification is important because it provides information about the potential severity of a device problem. However, even a recall that isn't classified as the most serious can be significant for a patient who relies on that device.
One Device Problem Can Affect Patients for Years
The experience of Philips Respironics demonstrates how a medical device problem can grow into a much larger patient-safety issue. Philips Respironics faced a major problem involving a foam material used in certain breathing machines. The issue resulted in years of recalls, regulatory oversight and litigation.
In 2024, a federal court approved an agreement requiring Philips to take steps to address the recall. Philips also agreed to pay about $1.1 billion to settle lawsuits brought by people who said they were injured or harmed by the recalled products.
What Should Patients Do?
A recall does not necessarily mean that every patient who has used the device has been injured. However, a recall is an important reason to pay attention and talk with your healthcare provider.
If you learn that a medical device you use has been recalled, it is a good idea to:
- Find out exactly which product or model is affected.
- Follow the manufacturer's or FDA's instructions.
- Talk with your doctor about whether you should continue using the device or consider an alternative.
- Ask what symptoms or complications you should watch for.
- Keep records of the device, recall notice, medical treatment and any problems you experience.
Most importantly, don't ignore symptoms or complications simply because you aren't sure whether they are related to the device. Discuss your concerns with your healthcare provider.
When a Device Causes Serious Harm
Medical technology has improved and extended countless lives. But medical devices can fail, and patients can suffer serious consequences when a defective device, inadequate warnings, improper training or other negligence contributes to an injury. Patients may face additional medical treatment, permanent disability, lost income, emotional distress or other damages. In the most tragic cases, a medical device failure can contribute to a patient's death.
If you or a loved one has suffered serious harm due to the failure or malfunction of a medical device, it's worth asking questions. Consider reaching out to a top attorney for medical device injury in Philadelphia, who can help you understand your rights and evaluate your potential legal options. In the last few years, almost every teaching hospital in the city of Philadelphia has paid 8-figure verdicts and settlements to clients of Tom Duffy.