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What happens when a medical device is recalled?

When a medical professional treats residents in Montana, it is likely that a treatment plan will be designed for their injury, illness or disease. While this often includes medicine or surgery, sometimes it means having a medical device place in the patient's body. While these devices are designed to help the patient, sometimes these devices to not function properly or are defective. When this occurs, a medical device recall will likely occur.

When a medical device is recalled, this often means that the product is found to be defective or dangerous and its continuous use could pose serious health risks. However, when a recall happens, this does not always mean that the patient will have to stop its use and return it much like other product recalls.

If a medical device occurs, this often means that the device must be checked, adjusted or fixed. For example, if a patient has an artificial hip and it is recalled, this does not always mean that the patient must have the recalled artificial hip removed and replaced. In some cases, adjustments or repairs could be completed without such an invasive surgery.

Recalls are considered either a correction or a removal. In cases where it is a correction, action that might be considered in line with this type of recall include inspecting the device for issues, repairing the device, adjusting settings, re-labeling the device and monitoring the patient for health risks. For a removal recall, the only way to address the issues with the device is by removing it; therefore, the patient will have to have the device removed.

If a medical professional fails to take the necessary steps in either a correction or removal recall of a medical device, a patient might have certain recourses available. If a manufacturer, distributor or medical professional fails to make a timely recall and notify the FDA about the recall, liability could be placed on any or all of these parties. Injured patients could file a products liability claim for the losses and damages caused by the incident.

Source: Fda.gov, "What is a Medical Device Recall?" accessed Dec. 7, 2015

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