Medical Device Recalls

Medical device recalls do occur so it is important to know that if you are in need of a medical procedure, it’s not a bad idea to ask the physician the following questions:

1) How long the technology been available?

2) Have there been any recalls associated with the technology?

3) Are there any complications that may result from using the technology or complications risks associated with the procedure?

All medical procedures do have some level of risk. When a physician proposes a medical procedure in a treatment plan, they review the risks, benefits and alternatives.  They also inform you of the ways you can reduce the risks.  Physicians also consider the level of risk compared to the benefits and they review this information with you. Yet, since you may be ill and your primary focus is managing through the illness, you may forget to note information about the technology.  Thus, it is advised to inquire about technology or research the technology online before undergoing a medical procedure.

Medical device recalls are sent out to physicians when a defect in the technology is discovered by the manufacturer or the Food and Drug Administration. When manufacturers receive information about physicians, who have discovered defects or injuries resulting to patients due to technology defects, they are obliged to report the defect or injury to the FDA. At this time, the FDA and the manufacturer usually work together to inform physicians about the defect, the risk of injury, and the need to remove it from the physician office or hospital for return to the manufacturer.  Class One Recalls are the most serious.

If you are need of a lawyer due to personal injury, please contact attorney Burton A. Padove at Padove Law at  (219) 836 2200.