What is a Medical Device Recall?
When a person undergoes a medical procedure involving the use of a medical device, that person trusts it is safe and effective. Unfortunately, this is not always the case. When it becomes clear that a medical device is causing unexpected harm to consumers, a medical device manufacturer must take measures to address such serious problems. One such method is a Medical Device Recall.
A medical device manufacturer, not the Food and Drug Administration, is responsible for the safety of the medical devices it makes. Accordingly, when a medical device is found to pose a risk to health, to be defective, or both, the manufacturer of the device may voluntarily recall that device to avoid further harm to consumers. If a manufacturer neglects its obligations and refuses to recall a device voluntarily, the FDA can require it to do so.
Medical device recalls are extremely important because they notify consumers and medical providers that a potential issue exists. A recall may also provide instructions, such as:
- Stop using the device
- Destroy the device
- Check the device — collect and inspect for defects
- Adjust the device — such as change a setting
- Repair the device — fix a problem
- Use the device only in particular circumstances
If a device has been implanted into a patient — such as a pacemaker, artificial hip or knee — the recall might require that the patient be monitored closely, or that the patient and medical provider discuss removing and replacing the device.
If a consumer suffers harm caused by a defective medical device, the manufacturer of the device may be legally responsible for damage to the health and well-being of the consumer. For example, financial awards can compensate injured patients for lost wages, medical bills, and pain and suffering caused by the defective device.
In the unfortunate case that a person dies as the result of a defective medical device, the surviving family of the victim may be able to file a wrongful death claim against the manufacturer of the medical device.
If you are using a medical device that has been recalled, speak to your doctor immediately. If you have been harmed by a defective medical device, speak to a Colorado dangerous medical devices attorney. Call the law firm of Burg Simpson Eldredge Hersh and Jardine, P.C. Call 303-792-5595 or contact us online now for a Free Case Evaluation.