Defective Medical Devices

Defective products are more common in every day life than one might expect.  Every year, car models are recalled, boat engines revamped, children's toys plastered with warnings and proper usage stickers.  Likewise, medical devices are prone to malfunction, may be tainted and cause injury or death to a patient.  For these reasons, the government struggles to create a safety net of rigorous testing; unfortunately, the true dangers of products are oftentimes not realized until after the fact.  Sometime the FDA will recall a dangerous or defective medical device.  A recall is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.

Examples of the types of actions that may be considered recalls:

• Inspecting the device for problems
• Repairing the device
• Adjusting settings on the device
• Re-labeling the device
• Destroying device
• Notifying patients of a problem
• Monitoring patients for health issues
   

Sometimes a company may have concerns about a group of products, but it cannot predict which individual devices will be affected. To be on the safe side, the company may recall an entire lot, model, or product line.

Who recalls medical devices?

In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it recalls the device (through correction or removal); and notifies FDA.

Legally, FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, FDA has rarely needed to require a medical device recall.

What happens in a medical device recall?

When a company recalls a medical device, it contacts directly 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); supplies information to help users identify the product and take steps to minimize health consequences; and takes action to prevent the problem from happening again.

FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. During a medical device recall, FDA works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again; conducts audits to make sure the recall efforts are appropriate and effective; makes sure the company takes necessary actions to prevent the problem from happening again. 

FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, Class II, and Class III. This classification process usually takes place after the company has issued its recall.

• Class I  High risk
• Class II  Less serious risk 
• Class III  Low risk   

FDA’s classification determines the number of checks the company has to make and the number of audits FDA will conduct to ensure the effectiveness of the recall action. It is intended to make sure that the company has followed through on its decision to implement the recall action

Note: The responsibility for an adequate recall belongs to the manufacturer. The decision and timing of FDA’s recall classification does not change or delay the company’s obligation to take appropriate action.

What is a Class I recall?

A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.

In a Class I recall, the company: notifies their customers (i.e. distributors or vendors), and directs them to notify the intended recipients of the device (i.e. other vendors, hospitals, nursing homes, outpatient treatment facilities, doctors, or individual patients). The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reason for the recall, and instructions about how to correct, avoid, or minimize the problem. It should also provide a telephone number for questions related to the recall.

FDA posts consumer information about all Class I recalls on its Medical Device Recalls website.

What is a Class II Recall?

A Class II recall usually represents a less serious risk than a Class I recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

In a Class II recall, the company notifies their customers (i.e. distributors or vendors) and sometimes asks them to notify the intended recipients of the device. FDA generally does not issue a press release or expect the company to issue a press release for Class II recalls, unless there is a specific need to do so (for example, if the device could affect the health of a large number of people, if patients need more information, or if the recalling company could not reach every intended recipient).

What is a Class III Recall?

A Class III recall represents a less serious risk than a Class II recall. In a Class III recall, there is little chance that using or being exposed to the device will cause health problems. However, because the product violates FDA law, there is still a need to take an action to address the problem.

In a Class III recall, the company notifies their customers (i.e. distributors or vendors). FDA would not issue a press release, and it would not expect the company to issue a press release.