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The How and Why of Medical Device Recalls

April 25, 2018

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Have you ever wondered how and why medical devices get recalled?  The Food and Drug Administration (FDA) regulates approvals and recalls for food, drugs, and medical devices.  While the FDA must be provided with reasonable assurances that every medical device it approves for use is safe and effective, sometimes problems arise.

What is the Basis for a Medical Device Recall?

A wide variety of events or circumstances can lead to a recall.  A company usually tracks manufacture, handling, and performance of its medical devices.  It can detect events such as production failures, improper handling, or contamination during manufacture or transport.  In addition, a company will find out about unanticipated problems by users of the device.  Each of these events can form the basis for a recall.

The FDA has developed a classification system to identify the degree of hazard posed by the recalled products.  The classes are:

• Class I – dangerous or defective products that could cause serious health problems or death
• Class II – products that might cause a temporary health problem, or pose only a slight risk of a serious problem
• Class III – products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing requirements

If an FDA-regulated medical device is found to be defective, or is potentially harmful, then either the company or the FDA recalls the product.  A recall can involve a variety of precautionary and protective steps, from correcting a problem with the device to removing it from the market altogether.

Who Recalls a Medical Device?

Both the FDA and the company are concerned about protecting the health of those using FDA approved products.  Most of the time a company will become aware of a problem or potential problem before the FDA.  In these cases, the company will normally recall the product voluntarily.  Sometimes the FDA becomes aware of a problem, or is made aware of an issue by the Centers for Disease Control and Prevention (CDC), and then raises concerns with the company, which then recalls the product.  Only in rare instances will the FDA itself initiate a recall.

What if I am Using or Have Been Implanted with a Recalled Medical Device?

The best course of action will need to be determined in concert with your medical provider.  At least the devices should be checked for adequate performance.  It may be possible to adjust or fix the device to address the problem.

If an implanted device is recalled, it does not always have to be removed and replaced.  When the implanted device has the potential to fail unexpectedly or have other problems, companies often instruct doctors to contact their patients to discuss the risk of removing the device, compared to the risk of leaving it in place.

Contact your doctor about how you should proceed.

Brookman, Rosenberg, Brown & Sandler Defective Medical Device Lawyers Serve the Philadelphia Area

If you have been using or are implanted with a defective medical device, then you will need to act to protect your health.  Contact one of our Philadelphia defective medical device lawyers at Brookman, Rosenberg, Brown & Sandler for a free consultation. Call us at 215-569-4000 or contact us online. We are centrally located in Philadelphia, Pennsylvania, and we represent clients throughout the surrounding areas.