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What is a medical device recall and what does that mean for you?

Medical devices are wonderful tools that can improve the health and well-being of a New York patient. However, there are sometimes problems with these devices, and often, people do not know about a problem until they are already using the device or after implantation. When there is an issue, there is typically a medical device recall. 

When a product is under recall, it means that either repairing the device or removing the device altogether is necessary to ensure that it does not cause harm to the user. There are two options to do this, either by removal or by correcting the device. Typically, the doctor who implanted or prescribed the device will notify the patient of a recall.

What happens during a recall?

When a company decides that it is necessary to initiate a recall, it will be through either correction or removal. The company may correct the problem and fix the devices immediately, or it may be necessary to remove them from sellers and distributors. During a recall, the manufacturer may determine that it is necessary to do any of the following:

  • Repair problems
  • Inspect the device
  • Notify patients and users of a problem
  • Monitor patients for health problems
  • Adjust settings on the device
  • Relabel the medical product
  • Destroy the medical device

When a manufacturer, distributor or other party realizes that an issue with a medical device exists that violates the standards of the Food and Drug Administration, that party is responsible for contacting the FDA and initiating a recall.

Problems with implanted devices

A medical device recall can be particularly frightening if it is for a device implanted in your body. Sometimes, an inspection and adjustment is all that is necessary for you to be safe. In more serious cases, your doctor may discuss with you the risks associated with removing the device. You should receive prompt notification of any problems or newly discovered risks.

Do you have grounds for a civil claim?

A dangerous or defective medical device can cause you significant harm. If you believe that you are experiencing problems due to a defective device or you did not receive appropriate notification of the dangers of a product that caused you harm, you have rights.

Manufacturers are responsible for distributing safe products and informing users of any potential problems. If you believe that you have grounds to move forward with a civil claim because of a defective medical device or product, you may find it beneficial to begin by seeking a complete explanation of the legal options available.

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