Amplatzer Steerable Delivery Sheath Lawsuit: What’s the buzz all about?

by | Apr 3, 2024 | Medical Devices, Product Liability

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Every year in the United States, people undergo an enormous number of medical procedures. Amplatzer Steerable Delivery Sheath is one of the most frequent cardiac procedures; however, many common people are unaware of what it is, what the procedure is, and about its negative impacts that have the possibility of causing serious injuries. Even some people sued Abbott in the Amplatzer Steerable Delivery Sheath lawsuit.

In this blog, we have thoroughly discussed all the details regarding the Amplatzer Steerable Delivery Sheath lawsuit.

What is the Amplatzer Steerable Delivery Sheath?

The Amplatzer Steerable Delivery Sheath is a medical device used in interventional cardiology procedures. It offers a way of positioning and delivering other devices, such as occlusion devices for closing structural heart defects like atrial septal defects (ASDs) or ventricular septal defects (VSDs). This steerable feature supports the medical professional, with their ability to handle and help to control the procedure accurately within the cardiovascular system during minimally invasive procedures, to ensure accurate device placement.

How does Amplatzer Work?

The Amplatzer Steerable Delivery Sheath acts as a tool and plays an important role in minimally invasive cardiac interventions, allowing healthcare professionals to navigate and deliver various cardiovascular devices with precision and efficiency.

Now let’s discuss how the Amplatzer Steerable Delivery Sheath works.

During surgery, the steerable sheath is used to deliver the Amplatzer Amulet Left Atrial Appendage Occluder by maneuvering it into the heart.

In order to ensure that no portion of the ASDS is still inside the patient after surgery, doctors completely remove it.

For people who cannot tolerate anticoagulants, left atrial appendage closure is a different method of preventing stroke.

The Amplatzer Amulet Left Atrial Appendage Occluder from Abbott can be implanted more quickly and precisely thanks to the ASDS. In complicated circumstances, it might help cut down on operation time and minimize problems.

Let’s get deep into the topic, from the harmful effects and injuries and their reasons to the Amplatzer Steerable Delivery Sheath lawsuit.

Potential Side Effects of the Amplatzer Steerable Delivery Sheath

Side effects from a medical procedure and the injuries from it are the main reasons why people file an Amplatzer Steerable Delivery Sheath Lawsuit. The use of Abbott’s Amplatzer Steerable Delivery Sheath has a number of dangerous and even fatal side effects.

Air embolism, arrhythmia, hemorrhage, heart failure, high blood pressure, low blood pressure, stroke, thrombosis, transient ischemic attack, and vascular failure are a few of these. Abbott also issues a warning regarding the proper usage of the device and the danger of introducing air during Amulet delivery.

Serious injuries from air embolism include:

Acute decrease

Possible reasons for a decrease in blood flow during the use of a sheath like the Amplatzer Steerable Delivery Sheath could include:

  • Vessel Obstruction
  • Vasospasm
  • Thrombosis
  • Dislodgment of Plaque
  • Hemorrhage


Manipulation of catheters and sheaths in certain areas of the heart can stimulate the vagus nerve, which can result in bradycardia.

Other possible causes of bradycardia during or after a medical procedure like catheterization, where a sheath like the Amplatzer Steerable Delivery Sheath might be used, could include:


When using the Amplatzer Steerable Delivery Sheath, desaturation, or low levels of oxygen in the blood, can occur during or after medical procedures. But there are several potential reasons why a patient may experience low blood oxygen levels in a medical setting:

  • Hypoxia due to sedation
  • Pulmonary Embolism
  • Respiratory Compromise
  • Hyperventilation
  • Pain and discomfort
  • Cardiac output changes

Low blood pressure

Low blood pressure, or hypotension, can occur during medical procedures involving devices like the Amplatzer Steerable Delivery Sheath. While the sheath itself is not typically a direct cause of low blood pressure, sometimes allergic reactions and pre-existing conditions may result in low blood pressure.


When using devices like the Amplatzer Steerable Delivery Sheath, chances of tachycardia, which is an excessively rapid heartbeat, can occur during or after medical procedures.

However, there are some reasons that may cause tachycardia, like stress, anxiety, fever, and any kind of infection due to the implant that can result in tachycardia.

Fatal stroke

High blood pressure brought on by hypertension or prescribed medications can also cause a fatal stroke in a patient with an implant.

If your doctor provided you with a medication without fully informing you of its adverse side effects or if they chose the incorrect medication for your illness and it caused you any kind of serious injury, you could file a medical malpractice lawsuit against the medical professional.

Along with the usual ASDS-related potential side effects, a repeatedly reported reason for the side effects is caused by air embolisms, which allow the air bubbles into the bloodstream of a patient during a medical procedure. The number of people who suffered side effects because of air embolisms was higher than expected. In 26 of these cases, Amplatzer steerable delivery sheath issues led to 16 injuries. Even the Abbott recall was sparked by these occurrences.

Why is Abbott’s Catheter Dangerous?

Amplatzer Steerable medical devices with sheaths are usually considered safe. It aids in minimizing the potential hazards related to difficult left atrial closure surgeries. Compared to implementing rigid sheaths, these sheaths help to finish the procedure in a shorter time and distribute the implant more accurately.

Abbott’s design, however, makes use of a different connector than other comparable devices, which may raise the possibility of abuse. The literature on devices makes recommendations for risk-reduction measures. Clinical trials that are now planned also aim to compare the effectiveness and safety of steerable devices to their rigid counterparts.

Despite its advancements, the Amplatzer Steerable Delivery Sheath was recalled in June 2023 due to the fact that the number of complications experienced by patients was higher than expected when using it in the corresponding medical procedure.

Abbott’s Amplatzer Steerable Delivery Sheath Recall

The U.S. Food and Drug Administration gave Abbott’s Amplatzer Steerable Delivery Sheath recall its highest classification—Class 1—indicating that using the device continues to pose a plausible risk of serious health injury or death. It is advised that you return any unused equipment, switch to the TorqVue 45-degree by 45-degree fixed curve distribution system for future Amulet implants, and send back the letter of acknowledgement.

People started filing the Amplatzer Steerable Delivery Sheath Lawsuit in February 2023 on the product model ASDS-14F-075, which was distributed from October 4, 2022, to February 22, 2023.

In July 2023, plaintiffs started investigating their legal options and speaking with leading medical device injury attorneys nationwide.

On June 12, 2023, Abbott voluntarily recalled the Amplatzer Steerable Delivery Sheath due to a design flaw with the item. The overall reported incidence rate of observed or potential air embolism during use as a result was 0.77%.

The majority of the 26 recorded instances resolved without the need for treatment, although some people necessitated medical attention.

Abbott’s Amplatzer Steerable Delivery Sheath Lawsuit

The main reason for people to file an Amplatzer Steerable Delivery Sheath lawsuit is because it increases the chance of an air embolism in patients. The introduction of air bubbles during surgery has the potential to result in a number of severe injuries or fatalities.

According to the lawsuit, air embolism is seen as the reason for harmful side effects. It allows the air bubbles to enter the vein or artery. It is a rare but potentially dangerous medical condition. It’s possible for patients to have little or no symptoms at all. However, there is a chance for more severe side effects, such as cardiovascular collapse and death.

The Amplatzer Amulet Left Atrial Appendage Occluder is delivered into the chambers of the heart by the cardiac catheter known as the Amplatzer Steerable Delivery Sheath. To date Abbott reported 26 ASDS-related occurrences with 16 injuries but no fatalities. Any sheaths that aren’t used by healthcare providers should be returned to the supplier.

Amplatzer Steerable Delivery Sheath Lawsuit 2024 Update

Injured people are now seeking a personal injury legal firm’s assistance to file an Amplatzer Steerable Delivery Sheath Lawsuit.

Let’s now see what the eligibility criteria are and who can be eligible to file an Amplatzer Steerable Delivery Sheath Lawsuit.

Eligibility for the Amplatzer Steerable Delivery Sheath Lawsuit

A cardiac catheterization procedure using ASDS must have been performed on a person who had suffered an injury that necessitated medical attention in order for them to be qualified to file a lawsuit. Families of loved ones who passed away as a result of ASDS issues are also eligible to initiate a case.

You can evaluate your situation and decide whether you are eligible to pursue an ASDS air embolism lawsuit by speaking with an experienced law firm.

As you begin, investigate your litigation possibilities, it can be helpful to have your medical documents prepared for discussion with a lawyer.

To conclude, the Amplatzer Steerable Delivery Sheath Lawsuit has reached a resolution with important implications for the medical device industry. This case highlights the significance of a thorough medical record review and expert opinion in legal matters involving medical devices. Companies specialize in medical record review by offering services that can play a crucial role in such cases, providing attorneys with the comprehensive insights they need for effective litigation.

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MedLegal360 is a specialized author in medical-legal matters, providing clear, authoritative insights on healthcare legislation and personal injury litigation for professionals and the curious.

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