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Why Do Medical Devices Fail?


Medical devices have come a long way in making patients’ lives more convenient. However, there have also been many issues with medical devices that have led to patients suffering injuries and even death. According to the U.S Food and Drug Administration (FDA), there have been over five million reports of failed medical devices in the past 10 years. If you or someone you know suffered injuries due to a failed or defective medical device, there are a few things you should know.

Causes of Failed Medical Devices

Medical devices usually fail as a result of a faulty design or insufficient testing during the production of a device. Other reasons for medical device failures include devices produced by startup companies with a lack of expertise, as well as reusing devices that should not be reused. Medical devices that have failed in the past include:

  • Heart pump controllers
  • Lap bands
  • Surgical bands
  • Blood clot filters
  • Pacemakers
  • Heart valves

Lack of Clinical Studies

Clinical studies are important because they help discover any potential issues with medical devices. Failing to perform clinical studies puts patients’ health and safety at risk. Unfortunately, due to the Medical Devices User Fee and Modernization Act, many companies are being granted approval for their devices without having to submit clinical testing data. The only requirement is that companies submit a 501(k) log of any modifications that show that the device is at least safe and effective as any other legally marketed device.

Notification About Recalled Medical Devices

The FDA updates its Medical Device Recall Database regularly in order to keep the public informed about medical device recalls. It also lets people know when the recall is terminated. The information on the Medical Device Recall Database is detailed and makes all information about the recalled medical device available, and whether the device needs to be removed from the patient. If it does not need to be removed from the patient, the database will let the public know if it needs to be checked, repaired, or adjusted.

There are three classes of a medical device recall: Class 1 recalls are the most important tier because they have the most severe effect on the patient, Class 2 indicates that the device has the potential to lead to illness or injury, and Class 3 is the least dangerous and is not likely to cause illness or harm to the patient.

Philadelphia Defective Medical Device Lawyers at Brookman, Rosenberg, Brown & Sandler Represent Clients Injured Due to Failed Medical Devices

Injuries as a result of a failed medical device is an unfortunate reality for many patients. If you or someone you know was injured as a result of a failed medical device, contact a Philadelphia defective medical device lawyer at Brookman, Rosenberg, Brown & Sandler. Our experienced lawyers will fight for your rights and obtain the compensation you deserve for your suffering. For a free consultation, contact us online or call us at 800-369-0899. Located in Philadelphia, we proudly serve clients throughout Pennsylvania and New Jersey, including Delaware County, Chester County, and Philadelphia County.