San Diego product liability attorneys, patients often ask us what it means when a medical device is recalled.
Given that the devices are intended to improve health, we can understand
why it can be concerning to learn there may be a problem.
Medical device recalls are initiated when a device is found to violate
U.S. Food and Drug Administration regulations. This may mean that the
medical device is defective, it poses a risk to health, or it is both
and a risk to health.
In most cases, the device manufacturer voluntarily recalls the device.
When a company recalls a medical device, it:
- Notifies the customers who received the product from them, and takes steps
to reach others who need to be notified (for example, by issuing press
releases or providing detailed instructions);
- Provides information to help users identify the product and take steps
to minimize health consequences; and
- Takes steps to prevent the problem from happening again.
The role of the FDA is to oversee the recall to make sure that the actions
the company takes are adequate to protect the public health. In addition,
if a device maker fails to recall a device on its own, the FDA will often
step in. For example, if a company refuses to recall a device that is
associated with significant health problems or death, the FDA can compel
the company to recall the device.
For patients, a medical device recall does not always mean that you must
stop using the product. In many cases, the medical device just needs to
be checked, adjusted, or fixed. If an implanted device like a pacemaker
is recalled, it does not always have to be removed. Rather, patients are
often instructed to contact their doctor to discuss the risk of removing
the device compared to the risk of leaving it in place.
Of course, there are some cases where defective medical devices lead to
serious complications and other health problems. When this happens, it
is advisable to consult with an experienced lawyer to determine if you
may be eligible for compensation.
If you or someone you care about has been seriously injured by a dangerous
or defective medical device, don’t hesitate to contact
a San Diego product liability attorney at the Law Offices of Robert Vaage
for a free consultation.