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Defective Medical Devices

Injuries and Death from Risky Medical Products

As a patient or consumer, you should be able to trust the medical devices your doctors and other medical staff are using or implanting into your body. However, these devices are not always safe and could cause you or your loved one permanent or fatal injuries.

FDA MEDICAL DEVICE RECALLS

The FDA is in charge of monitoring all medical devices and drugs available for consumer use. In most cases, a company, including manufacturers and/or distributors, will usually recall their medical devices on their own or voluntarily. However, if a medical device is associated with significant health problems or death, the FDA may require a company to recall a device immediately.

When a company recalls a medical device, it

  • Contacts the customers who received the product from them, and takes steps to reach others who need to be notified usually by press release
  • Supplies information to help users identify the product and take steps to minimize health consequences
  • Takes action to prevent the problem from happening again

CLASSIFICATION OF MEDICAL DEVICE RECALLS

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
    • Product may cause serious health problems or death.
  • Class II – Less-Serious Risk
    • Product may cause temporary or reversible health problems.
  • Class III – Low Risk
    • There is little chance that the product will cause health problems. The FDA nor the company is required to issue a press release.
DEFECTIVE MEDICAL DEVICES COULD INCLUDE:
  • Pacemaker Recalls
  • Medtronic Recalls
  • Defibrillator Recalls
  • Implantable Cardioverter Defibrillators – ICD Recall
  • Shoulder Pain Pumps
  • Kugel Mesh
  • Surgical Implants

HAVE YOU BEEN INJURED?

If you’ve been injured, we can help. Contact us