Defective Medical Devices

 

 

 

 

A defective medical device poses a serious health risk to people requiring its use. Millions of people use a variety of medical devices under the belief that they are safeguarded from a serious health risk. Medical device defects leave patients at serious risk of incurring a debilitating injury or even death if the issue goes undetected.

A medical device is an instrument designed to aid in the diagnosis and/or treatment of health-related issues. When functioning properly, medical devices have the potential to vastly improve the lives of people suffering from chronic diseases, illness or health-related abnormalities. As the technology incorporated in the design of medical devices continues to improve, so too does the potential with which said devices may aid in the diagnosis and treatment of many health-related issues.

Medical Device Approval

In order for medical devices to be marketed to the general public, they must first be approved by a division of the Food and Drug Administration (FDA) known as the Center for Devices and Radiological Health (CDRH). The CDRH has the responsibility of testing and approving each and every medical device to ensure that it is both safe and effective.

The CDRH often discovers medical device defects that prevent approval. If medical device defects are found to be widespread, the FDA may request a voluntary manufacturer recall or issue one itself if the manufacturer refuses to comply. In addition to potentially causing death, defective medical devices may also cause patients to experience a great deal of pain and suffering.

Medical Device Defects & Recalls

Some of the more notorious medical devices that have recently garnered a great deal of attention because of widespread defects include:

• Guidant medical devices
  • Pacemakers
  • CRTs
  • ICDs
    
• Medtronic medical devices
  • Pacemakers
  • CRTs
  • ICDs

Many brands of the aforementioned medical devices have either been recalled voluntary or as a result of FDA suggestion. Patients implanted with any such medical devices are advised to consult with a physician to determine the best course of action.

Defective Pacemakers

Recent headlines have surrounded the recall of defective Guidant pacemakers and defective Medtronic pacemakers (Guidant and Medtronic have also had difficulties with regards to defective ICDs). Pacemakers are medical devices designed to monitor heart rate, applying the appropriate therapies if said rate is higher or lower than normal. Pacemakers have the potential to save a great many lives by preventing serious issues that could result in heart failure.

Defective pacemakers pose a serious risk because they are unable to serve their purpose, while giving patients a false sense of security. Serious defects can prevent a pacemaker from applying the appropriate therapies when necessary, or can cause therapies to be applied unnecessarily.

Defective Medical Device

Medical device manufacturers are responsible for any injuries or deaths caused as a result of each and every product that they market. In order to safeguard consumers from medical device defects, manufacturers are responsible for testing the safety and efficacy of their products. As such, they are liable for any injuries or deaths that result from a defective medical device.

If you or a loved one has been injured or killed as a result of a medical device defect, contact the law offices of Aylstock, Witkin, Kreis & Overholtz to speak with our qualified professionals about compensation. Aylstock, Witkin, Kreis & Overholtz boast some of the most experienced personal injury lawyers Pensacola, Florida has to offer. Contact us today at 877 810 4808 for a case evaluation.