A Teleflex catheter recall has been announced on reports that parts of the catheter can separate and potentially cause serious bleeding. At least 13 adverse events have been reported with the product, including one 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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Recall Includes Over 47,000 Devices
Teleflex Inc. announced the worldwide recall of its Arrow International intra-aortic balloon (IAB) catheter kits and percutaneous insertion kits. The Arrow IAB is inserted in the aorta and provides mechanical circulatory support for cardiac patients, by inflating and deflating at different phases of the cardiac cycle to increase cardiac output and decrease the work of the heart. The U.S. Food and Drug Administration (FDA) has been notified of the recall of about 47,000 units (product codes and lot numbers) sent to hospitals around the world, according to the company’s letter to its customers dated February 11, 2016.
According to Teleflex, the recall is:
“due to the possibility that the sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. If bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. In addition, delay of treatment, interruption of treatment, or loss of [intra-aortic balloon] IAB therapy can occur.”
At the time of the recall, there were 13 adverse events reported; including six serious injuries and one death. The FDA has classified the recall as a Class I recall. The FDA defines a Class 1 recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
How a Teleflex Catheter 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 Arrow intra-aortic catheters 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 intra-aortic catheter, 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 Arrow intra-aortic catheters, 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 Teleflex catheter recall lawyer to learn more about their rights and remedies.
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