Vascular Solutions has recalled a defective medical device because of the potential for injury to patients who use the device. The U.S. Food and Drug Administration (FDA) has identified this medical device recall to be a Class I Recall. A Class I Recall is the most serious class of recalls because use of the medical device can result in serious injury or death due to the defect.

Why is the Guardian II Hemostasis Value Being Recalled?

Vascular Solutions is recalling this medical device because of a defect that can block blood supply to the heart or blood vessels causing an air embolism. The potential result is severe injury or death. The defect is in the low pressure seal. The defective seal may allow air bubbles into the device that cause the blockage. The Guardian II Hemostasis Value is used for patients who are receiving hemostasis therapy or for patients undergoing diagnostic or interventional catheterization procedures.

The FDA recommends that healthcare facilities immediately remove the medical device from their inventory and return it to the manufacturer. The FDA also encourages medical professionals and/or patients to report adverse events or side effects related to the use of the Guardian II Hemostasis Value to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program here.

What Can I Do If I Am Injured By A Defective Medical Device?

If you or a loved one is injured by a defective medical device, you may have a legal cause of action against the manufacturer and/or a third party. Because your time to file a personal injury lawsuit for a defective medical device is limited, you should contact a New Orleans medical device attorney as soon as possible. Your attorney will research the matter to determine who is responsible for your damages. The attorney will also research to determine if others have filed similar claims and lawsuits regarding the defective medical device. In some cases, a trust may already be established for those seeking damages after being injured by a defective medical device.

Depending on the facts of your case, you may be entitled to receive damages including but not limited to:

  • Compensation for past and future medical expenses
  • Compensation for past and future lost wages
  • Compensation for loss of earning capacity
  • Compensation for permanent disability, scarring, and/or disfigurement
  • Compensation for loss of enjoyment of life, physical pain, emotional suffering, and mental anguish

Hiring an experienced defective medical device attorney is your best chance of receiving a fair and just settlement when you have been injured by a medical device.

Contact A Law Firm That Handles Defective Medical Device Lawsuits

The defective medical device lawyers of The Olinde Firm handle defective medical device lawsuits in Louisiana and throughout the United States.

Contact our office for a free case evaluation. We never charge you an attorney fee until and unless we win compensation for your damages and injuries. Call us today at (504) 587-1440 or 1-800-587-1889 to schedule your free consultation.