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Is your medical device subject to a recall?

Like others here in West Virginia, you might rely on an implanted medical device to live a normal life after an injury or physical condition. The advances made in medical technology sometimes come with a price, however. Medical devices in particular could wreak havoc on your body since mistakes could occur during the manufacturing process.

When such manufacturing mistakes are discovered, the manufacturing company and the Food and Drug Administration issue recalls to deal with the defective product. In addition, patients and medical professionals also receive notices.

Types of actions for recalled medical devices

The FDA issues two types of recalls for medical devices:

  • Correction: The device requires some sort of corrective measures, but does not necessarily need removal.
  • Removal: The device requires removal due to the defect.

The nature of the problem dictates the type of recall issued.

How do you know the manufacturer or the FDA recalled your medical device?

If you failed to receive a notice directly, the following actions might intimate the issuance of a recall:

  • Your device requires a repair.
  • Your doctor wants to inspect the device.
  • Your doctor adjusts the device’s settings.
  • Your doctor destroys your device.
  • Your device gets re-labeled.
  • Your doctor tells you that you require monitoring for adverse health consequences.
  • Your doctor informs you of the recall of your device.

Any of these actions should prompt you to ask questions regarding the safety of your device.

What types of recalls does the FDA issue?

The FDA separates recalls into the following categories:

  • Class I: This type of recall comes with serious health consequences or death. Seek medical attention right away.
  • Class II: This type of recall suggests that any health consequences suffered only last temporarily and are most likely reversible. A reduced or slim chance of death exists under this recall. You should still seek medical attention since injuries remain a possibility.
  • Class III: This type of recall often poses no threat to you, but still requires attention.

Receiving a recall notice could cause fear and anxiety, so this information might help remove some of those concerns. However, what do you do if you suffered serious injuries due to a defective medical device? You might benefit from discussing your situation with an attorney. Medical device manufacturers, distributors and sellers might bear legal liability for your injuries.

Before that happens, however, a link between the defective medical device and your injuries must be made. This requires an investigation involving the review of your medical records, your injuries and the device itself. If a qualified medical professional establishes a causal link between your current condition and the device, a successful products liability lawsuit could result and provide you with the compensation you deserve.

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