A Guardian valve recall has been announced for the Guardian II hemostasis valves, designed for use in catheterization procedures, over an increased risk of air leakage that could lead to an air embolism (bubble in a vein or artery). The U.S. Food and Drug Administration (FDA) has labeled the recall as a Class I, the agency’s most serious classification of recall, which is used when there is a reasonable probability that use of the device could cause serious adverse health complications or death. Affected patients and their families may be eligible to pursue compensation with the help of a defective medical device lawyer.
For more information, contact Attorney Group today. Our consultations are free, confidential and without any obligation on your part. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
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Guardian Valve Recall Includes Over 26,550 Devices
Vascular Solutions, the manufacturer of the device, announced the Guardian Two hemostasis valve recall on March 3, 2016. The recall only affects the Guardian II hemostasis valves and does not include Guardian II NC hemostasis valves, the company said in a press release, saying air embolisms in the recalled valve could potentially result in serious injury or death.
According to massdevice.com, Vascular Solutions said it has not received any reports of injury or adverse events related to the issue to date, and instructed healthcare facilities with affected units to remove the products from their inventory and return them to the company. A total of 26,550 devices, manufactured between March 2015 and February 2016 and distributed between April 2015 and February 2016, are involved in the Guardian valve recall. The website reports that the recalled products are specific lots of model numbers 8210 and 8211, with 5,283 units distributed in the U.S.
How a Guardian Valve Recall Attorney Can Help
Medical device makers have a duty to provide safe products. If there are risks of harm associated with their devices, they also must provide adequate warnings. If a device maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
Patients who are injured by a defective Guardian II hemostasis valve may be entitled to compensation for damages, including:
- Medical expenses
- The permanency of the injury
- Pain, suffering, and mental anguish
- Loss of income or ability to work
If a patient dies from complications related to a defective hemostasis valve, family members may be entitled to compensation for the wrongful death of their loved one, including:
- Conscious pain and suffering of a loved one prior to death
- Pain, suffering, and mental anguish from the loss of a loved one
- Funeral expenses
Patients who have suffered severe complications from Guardian II hemostasis valves, as well as the families of those who have died as a result of complications with the device, are encouraged to seek the advice of a Guardian valve recall lawyer to learn more about their rights and remedies.
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