Weitz & Luxenberg is currently accepting legal cases from clients who became seriously ill, or had a loved one die, after using an Amplatzer Steerable Delivery Sheath cardiac catheter. This medical device is used in heart procedures and was manufactured by Abbott.
Abbott recalled its Amplatzer Steerable Delivery Sheath (ASDS) due to a recognized increased risk of air embolism. Using this device may cause serious injuries and significant health consequences, including stroke and death.
On July 26, 2023, the U.S. Food and Drug Administration (FDA) classified this recall as a Class 1, the most serious type of recall. A Class 1 recall indicates the FDA’s level of concern regarding the risk of serious injury or death from use of this medical device.
Abbott’s Amplatzer Steerable Delivery Sheath devices were distributed from October 4, 2022, through February 22, 2023. A total of 672 devices have been recalled across the U. S. The firm initiated the recall on June 12, 2023. (1)
Abbott Catheter Is Dangerous
Abbott’s Amplatzer Steerable Delivery Sheath “is a cardiac catheter inserted through the skin.” The catheter “provides a pathway for catheter-based devices to be introduced into the chambers of the heart.” Specifically, this device delivers the Amplatzer Amulet Left Atrial Appendage Occluder. (2)
This device is used in left atrial appendage cardiac catheterization procedures. This catheter device is dangerous because it can introduce air embolisms — air bubbles — into your heart. The potential for death is very real.
Air Embolisms Can Be Deadly
Abbott recalled this device “due to an increased risk for air bubbles (air emboli) to be introduced into patients who have procedures with this device.” At the time of the recall, Abbott has reported 26 incidents and 16 injuries and had not reported any deaths. (3)
According to the FDA, an “Air embolism can lead to injuries such as sudden (acute) reduction in blood flow to the heart (indicated by ST elevation), fast or slow heartbeat (tachycardia or bradycardia), low blood pressure (hypotension), and lack of enough oxygen in the blood (desaturation). Air embolism can also potentially lead to serious health consequences including stroke and death.” (4)
FDA Class 1 Recalls
Recalls are actions a company takes “to remove a product from the market.” Sometimes the company initiates the recall. Sometimes the FDA requests a company to recall a dangerous device. And, in some situations, the FDA can order a company to recall a defective device under statutory authority. (5)
A Class 1 recall refers to “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.” (6)
Who Is Affected by Abbott Steerable Delivery Sheath Recall?
Anyone who underwent a cardiac catheterization procedure using an Abbott Steerable Delivery Sheath placed into distribution between October 4, 2022, and through February 22, 2023, is affected by this recall.
The FDA advises medical professionals to return any unused devices to Abbott. The FDA has instructed doctors to “[u]se the fixed-curve TorqVue 45°x45° delivery system” for any future cardiac catheterization procedures. (7)
In a letter sent to healthcare professionals in June, Abbott claimed the company had reported a known overall “incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.” (8)
The letter also claimed, “Within those cases, customers have reported air emboli having resulted in transient ST segment elevation resolving spontaneously and, less commonly, hemodynamic instability requiring medical intervention.” (9)
W&L Helps If You Were Harmed by Recalled Medical Device
If you suffered an air embolism injury during a cardiac catheterization procedure, consider bringing a lawsuit. You can seek financial compensation for yourself or a loved one’s injuries.
Weitz & Luxenberg attorneys may be able to help you. Our defective medical device attorneys can assist you in exploring your legal options. We offer a free consultation.
Reach out to use if you experienced any of these medical issues from a cardiac catheterization procedure involving this recalled device. If you required medical intervention, you may be entitled to compensation for these injuries:
- Significant hemodynamic instability.
- Significant cardiac issues.
Weitz & Luxenberg is recognized nationally as a leader when it comes to representing clients harmed by defective medical devices. Call us now at (833) 544-0604. Or fill out the form on this page. One of our representatives will reach out to you.