When Does the FDA Recall Defective Medical Devices? [infographic]

“Medical devices” are a broad category of healthcare products that encompasses tongue depressors, thermometers, prosthetics, pacemakers, endosseous implants and everything in between. We rely on the products to help us live healthier lives, but sometimes a product is defective – even dangerous – and may be recalled by the manufacturer or even the U.S. Food and Drug Administration (FDA). If you’ve been sickened or injured as result of a defective medical device, a lawyer in Reno, NV, can work to get compensation for your injuries.

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When Does the FDA Recall Defective Medical Devices

Types of Medical Device

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating companies that manufacture and import medical devices into the United States.

Medical devices are divided into three categories: Class I, Class II and Class III. Regulatory oversight is most minimal on Class I devices and most stringent on Class III devices.

Class I devices include items such as bandages, medical gloves and simple, handheld medical instruments. These devices aren’t essential to maintaining someone’s life and are unlikely to cause to present a serious risk of injury.

Class II devices include acupuncture needles, powered wheelchairs, infusion pumps and surgical drapes.

Class III devices are devices that help sustain life or keep people from suffering serious health impairments, but have the potential to harm people if used incorrectly or if they malfunction. These would include pacemakers and defibrillators, for example.

FDA Regulatory Oversight of Medical Devices

Depending on the class of product, manufacturers and distributors may have to:

  • Register their company with the FDA
  • List the device with the FDA
  • Submit a Premarket Notification 510(k) to the FDA is the product is substantially equivalent to one already being distributed in the United States and then get FDA authorization
  • Apply for a Premarket Approval (PMA) if the device falls into Class III or if it is a Class I or II device with no substantially equivalent product
  • Request an Investigational Device Exemption (IDE) if the device is to be used in a clinical study to gather data in connection with the PMA or the 510(k)
  • Have the manufacturing plant undergo an inspection to ensure it Quality System Regulation (QS)/Good Manufacturing Practices (GMP)
  • Get the labeling and packaging approved by the FDA

When Devices Are Defective

In spite of all of the FDA oversight, medical devices can malfunction and seriously harm or even kill the patients who used the device in good faith. Under FDA rules, if the device causes a serious injury or death, or suffered serious malfunctions, manufacturers or distributors must report these events to the FDA. And if you’ve been the victim of such a device, you should immediately contact a Reno, NV, defective medical device lawyer.

When a device is defective, it may be recalled by the manufacturer or distributor. Recalls can vary in nature and scope. Sometimes a recall simply means you have to have the device checked or serviced to ensure that it functions properly. In the case of implanted devices that are determined to be defective, you’ll want to consult with a doctor who is familiar with the device and associated recall to discuss the possible risks of leaving the device implanted and periodically monitoring it versus the risks of having the device surgically removed.

Recalls are typically divided into two categories. According to the FDA, a “correction addresses a problem with a medical device in the place where it is used or sold,” while a “removal addresses a problem with a medical device by removing it from where it is used or sold.”

Medical device recalls are typically handled by the device’s manufacturer or distributor. These are called voluntary recalls, and the company issuing the recall must also inform the FDA.

In some instances the manufacturer or distributor may refuse to issue a voluntary recall. This occurs when the company doesn’t believe the device is dangerous or defective. In some instances, the company may worry that a recall will lead to a flood of product liability lawsuits, so it prefers to downplay the seriousness of the problem. In these instances, the FDA may require the company to issue a recalls.

The FDA maintains a database of recalled medical devices that includes both voluntary and involuntary recalls.

If You’ve Been Injured by a Defective Medical Device

If you’ve been injured by a defective medical device – regardless of whether it has been recalled – seek a doctor’s treatment immediately. You’ll also want to talk to a defective medical device lawyer in Reno, NV, because you may be able to recover money, known as damages, to compensate you for your injuries and associated medical expenses. Call the Law Office of Matthew L. Sharp at (775) 324-1500 to schedule a free consultation. Our product liability lawyers have experience working with individuals who have suffered injuries as a result of defective medical devices.