A medical device recall can typically be started by the company that made the device, as a voluntary recall, or by the government. Many companies, when they learn of issues that would mandate a recall, will simply issue it on their own to avoid having one issued by the government, but this is not always the case.
According to the Food and Drug Administration, a recall could give the company a chance to:
- Inspect the device to determine if there are any issues or problems. This may be needed in cases where some devices, but not all, have shown defects.
- Repair a device with a known defect.
- Put a new and more accurate label on the device.
- Change the device’s settings to increase functionality and safety.
- Destroy the device entirely if it is deemed to be unsafe and there is no way to repair it.
- Tell the patients who have the device that issues have been discovered. This notification can count as a recall even if the patient still has the device.
Now, there are less dire responses that may be taken when problems are suspected but the device may continue to work. In some cases, a recall will simply entail monitoring a patient to see if he or she is facing health issues that could stem from problems with the device. Again, this may be done when it’s thought that some devices are defective and some are not.
Have you been given a defective device? The ramifications can be serious when there is a malfunction, so it’s very important to understand all of your legal rights.
Source: FDA, “What is a Medical Device Recall?,” accessed Jan. 19, 2018