Abbott Recall Catheter Litigation: What You Need to Know

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What Are Abbott ASDS Catheters Used For?

The Abbott Amplatzer Steerable Delivery Sheath (ASDS) is a cardiac catheter. It is used during certain types of medical heart procedures. This product lets “catheter-based devices to be introduced into the chambers of the heart.” _{^{(1) (2)}}

What Abbott Catheter Products Are Recalled?

Abbott has recalled its Amplatzer Steerable Delivery Sheath cardiac catheter. This recall is because of the increased risk that this device can introduce air bubbles (air emboli) into patients undergoing certain heart procedures. ⁽³⁾

“Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart … fast or slow heartbeat … low blood pressure … and lack of enough oxygen in the blood.” These air bubbles can potentially lead to lead to stroke and death. ⁽⁴⁾

The U.S. Food and Drug Administration (FDA) has identified the Abbott OCT catheter recall as Class I. ⁽⁵⁾

Abbott ASDS Recall Is Due to Medical Injuries

Some patients have experienced air emboli. This led to transient ST segment elevation and hemodynamic instability. Although some patients had medical conditions that resolved spontaneously, others required medical intervention. ⁽⁶⁾ 

Abbott has instructed its customers to return any remaining unused Abbott OCT catheters. ⁽⁷⁾

Abbott Catheter Recall Is a Class 1

When the FDA learns about a company’s correction or removal action regarding a potentially defective device, the agency: ⁽⁸⁾

• Reviews the company’s proposed strategy to address the problem.
• Assesses the health hazard presented by the device.
• Determines if the problem violates FDA law.
• Considers potential violations.
• If appropriate, assigns the recall a classification to indicate the level of risk. 

Then the agency determines the seriousness of the recall: ⁽⁹⁾

• Class I is a “situation where there is a reasonable chance that a product will cause serious health problems or death.” ⁽¹⁰⁾

What Is a Medical Device Recall?

The FDA learned about problems with Abbott’s catheter. By law, Abbott had to correct or remove the device. In the case of its cardiac catheter, Abbott removed it from where it was being used or sold. ⁽¹¹⁾

Recalls occur when: ⁽¹²⁾

• A medical device is defective.
• When the device could be a risk to health.
• When the device is both defective and a risk to health.

Types of Recalls

Under federal law, when a device is defective, three options are possible: ⁽¹³⁾

• A company can voluntarily issue a recall. 
• The FDA can request a recall.
• The FDA can order a recall under statutory authority.

With voluntary recalls, a manufacturer issues a recall on its own. The Abbott catheter recall was voluntary. ⁽¹⁴⁾w

What Injuries and Complications Can Result from Using the Abbott Catheter?

You could experience medical complications if your surgeon used an Abbott catheter during your heart procedure. The major concern is “an increased risk of air bubbles. … Bubbles, also known as air emboli, can lead to”: ⁽¹⁵⁾

• Sudden reductions in blood flow to the heart.
• Low blood pressure.
• Insufficient blood oxygen. 

Most importantly, air bubbles can lead to stroke and death. ⁽¹⁶⁾

What Signs or Symptoms Should I Watch Out For?

You should watch for these possible severe air embolism symptoms: ⁽¹⁷⁾ 

• Difficulty breathing or respiratory failure.
• Chest pain or heart failure.
• Muscle or joint pain.
• Stroke.
• Mental status changes, such as confusion or loss of consciousness.
• Low blood pressure.
• Blue skin hue. 

If you notice any of these symptoms, seek medical attention immediately. You possibly could have an air embolism.

The Litigation Process 

Weitz & Luxenberg is accepting cases for litigation against Abbott. If you, or a loved one, suffered an air embolism after undergoing a medical procedure using an Abbott cardiac catheter, contact us. 

We have a lot of experience successfully handling injury cases due to defective medical devices. You may think you’re the only one who experienced a serious medical injury, but hundreds of people are going through the same thing. Let us help you, like we have helped thousands of others.

Why It Would Be Worthwhile to Go Through Litigation

Hiring a national law firm with a successful track record is key. Weitz & Luxenberg attorneys have been handling complex medical device litigation, such as this Abbott recall, for nearly 40 years.

We are prepared and ready to proceed with your Abbott catheter recall litigation. We have made it our mission to stand up to large, negligent corporations. We have secured billions of dollars on behalf of our clients.

We offer a free initial consultation. Our attorneys can provide legal advice regarding your individual situation. For more information, contact us at (833) 977-3437.