Clark, Love & Hutson, GP

What actions constitute a medical device recall?

While medical devises could provide many benefits to patients in Texas and elsewhere, it is possible that these devices fail to work in the way they were designed to. In these matters, a recall is likely issued, however, such a measure may not prevent serious or even fatal injuries from occurring because of a defective medical device.

What actions constitute a medical device recall? According to the U.S. Food and Drug Administration, when a problem occurs with a medical device that results in a violation of FDA laws, a recall is issued. A recall is an action take when a medical device is considered defective, could create a health risk or is considered both defective and a health risk to patients using the device.

However, a recall does not always mean that the patients must stop using the medical device or have it removed from their body. A recall sometimes means that the medical device needs to be checked, adjusted or repaired. Actions often considered to fit the definition of recall include inspecting the medical device for problems, repairing a failed device, adjusting the setting on the device, re-labeling the device, destroying the device, notifying the patient of a potential problem with the device or monitoring the patient for possible health issues associated with the medical device.

A medical device is either considered a correction, which entails the action listed above, or is could be considered a removal, which means that the only way to address the problems associated with the recalled medical device is by removing it from the patient.

When a manufacturer, distributor or other responsible party recalls a medical device voluntarily, two things must occur. First, the device must be recalled either through correction or removal. Second, the FDA must be notified of this voluntary recall of the medical device.

And while some medical devices are timely recalled, a manufacturer, distributor or doctor may fail to take proper steps to meet the terms of the recall. When a medical device harms a patient, it is important to understand whether a recall was issued, and if so, whether proper actions were taken in accordance with the recall. Failure to take timely and proper action can be considered negligent and the injured party could file a civil action such as a products liability claim to recover compensation for the person's injuries, losses and damages.

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