Balloon catheters are tiny tubes with inflatable balloons at the tip that get inserted into a body to remove obstructions, like plaque buildup in the arteries of the heart. Unfortunately, some types, specifically the NC Trek RX Coronary Dilatation Catheter and NC Traveler Coronary Dilatation Catheter, have been recalled since the balloons do not always deflate properly, causing the need for medical intervention and leading to subsequent complications.
The U.S. Food and Drug Administration (FDA) has prompted a Class 1 recall for these catheters, which is the most serious type of recall. One person has already died from their balloon catheter malfunctioning, and 13 people have experienced adverse effects such as heart attacks, reduced blood flow to the heart, or blood clots.
How Balloon Catheters Work
Coronary balloon catheters are used during a process called cardiac catheterization, which involves threading the catheter through an artery to the blood vessels of the heart. It can be used to determine if someone has a heart condition or to treat heart problems. Balloon catheters may also be used to:
- Find out if there is a blockage in an artery causing chest pain
- Measure oxygen levels in the heart
- Check that the heart is pumping blood properly
- Determine any pre-existing heart defects
- Check the heart valves
- Treat heart disease by widening heart valves or arteries
Why Would Someone Need a Coronary Balloon Catheter?
If a patient’s arteries are found to be clogged, it may be necessary for a coronary balloon catheter to be used to reopen them. A coronary balloon catheter may be used if someone has:
- Acute coronary symptoms
- Coronary artery disease
- Persistent chest pain in the cardiac region
- If you are at high risk of needing cardiac surgery
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Injuries Caused by Defective Balloon Catheters
Balloon catheters are meant to help improve the flow of blood to the heart by decreasing the blockages in arteries. However, when they malfunction, they can cause serious injuries or require additional procedures. If the balloon fails to deflate when doctors try to remove it from the body, it can cause:
- Reduced blood flow to the heart
- Damage to the artery or heart
- Heart attacks
- Strokes
- Blood clots
- Bleeding
- Death
For the catheterization process to work properly, the balloon catheter must be deflated and removed from the body. However, when doctors attempt to deflate these types of balloon catheters, some defective balloons don’t collapse. This can be a very frightening experience for doctors and patients.
When this situation occurs, doctors have to find another way to remove the balloon from the patient. They must use extreme caution since the balloon is operating near to the heart. The best way for doctors to remove the inflated balloon is to use additional surgery. However, this additional surgery can put patients, especially older ones, at greater risk for complications.
What Does a Class 1 Recall Mean?
More than 40,000 of these catheters, manufactured by Abbott Laboratories, have been recalled. The FDA puts out Class 1 recalls when a product’s malfunctioning can cause serious, irreversible injuries or even death.
Why are Class 1 recalls the most serious?
- A Class 2 recall means the product might cause serious injuries or death
- A Class 3 recall means the product is unlikely to cause injury or illness, but still violates the FDA’s regulations
Since there have been reports that these balloon catheters can cause incidences of death and serious injury, they fit the description of a Class 1 recall. The FDA requires manufacturers of recalled products to either correct the defective item or remove it from the market. So far, Abbott has informed customers to immediately stop use of these devices and to return any unused products.
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Manufacturer at Fault
Coronary balloon catheters are essential medical devices that are used to save lives. Since they are threaded throughout the body and operate near the heart, manufacturers of these devices should routinely test them for safety. Unfortunately, Abbott’s balloon catheters have been found to have been made with weaker material that likely causes them to fail to deflate.
Abbott Laboratories should be held responsible for creating medical devices that have a potentially life-threatening defect. Not only are they putting doctors in an uncertain situation, these defective devices can have terrible outcomes for patients.
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How Pintas & Mullins Can Help
If you have experienced complications from your balloon catheter malfunctioning, you may be eligible to receive compensation for your injuries. Let the experienced defective medical device lawyers at Pintas & Mullins help you every step of the way while you focus on recovering. Call (800) 794-0444 to learn more.
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