Amplatzer Steerable Delivery Sheath Recall and Injury Risks
Abbott recalled the Amplatzer Steerable Delivery Sheath in 2023 due to air bubbles, or air embolisms, blocking patients’ veins or arteries. Air embolisms can cause blood flow problems, stroke and death. Doctors use the delivery sheath in people with atrial fibrillation to reduce the risk of stroke.
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The Amplatzer Steerable Delivery Sheath (ASDS) is a heart catheter used with the Amplatzer Amulet Left Atrial Appendage Occluder in cardiac procedures to help patients with atrial fibrillation (AFib) lower their risk of stroke.
Together, these devices, manufactured by Abbott Laboratories, treat patients with AFib by closing off a part of the heart to reduce the risk of stroke and eliminate the need to take oral blood thinners.
The Amplatzer Steerable Delivery Sheath helps doctors implant the Amulet in the proper position to block off the heart’s left atrial appendage. In addition to preventing strokes, this process may also reduce procedure time and minimize complications.
Why Did Abbott Recall the Amplatzer Sheath?
Abbott recalled the Amplatzer Steerable Delivery Sheath in June 2023 because of an increased risk of air embolism, which occurs when air bubbles appear in a patient’s circulatory system and block a vein or artery. Abbott said the problems stemmed from a valve that allowed air into the system. The company recalled the devices and intended to release a modified steering sheath.
The company reported 26 incidents with the ASDS, including 16 injuries but no deaths. Abbott distributed the recalled devices from Oct. 4, 2022, to Feb. 22, 2023, and included 672 devices in the recall.
“An air embolism occurs when a bubble of air enters the bloodstream and blocks blood flow, which can cause serious problems in organs like the heart, lungs or brain. This often happens as a complication from medical procedures.”
Of those incidents, some patients who suffered from air embolisms had signs of a potential blockage of the coronary artery. This was resolved without medical assistance. Others had unstable blood pressure that led to reduced blood flow, and these people needed medical intervention.
The U.S. Food and Drug Administration (FDA) designated this recall as a Class I recall, the most serious kind, because using this device may lead to serious injury or death. The agency told medical providers to return any unused sheaths to Abbott.
What Can Go Wrong With the Amplatzer Sheath?
The risk of air embolism is the primary concern associated with the Amplatzer Sheath. Air embolisms can cause several problems, even stroke and death.
Complications from air embolisms include:
Fast or slow heartbeat
Lack of oxygen in the blood
Low blood pressure
Reduced blood flow to the heart
Stroke or death
Symptoms of an air embolism often come on suddenly and may happen during or shortly after your cardiac procedure.
Early signs include chest pain and coughing. Other symptoms include changes in mental state, respiratory distress, abnormal heart function, low blood pressure and weakness or paralysis.
Embolism
An embolism is the blockage of a blood vessel caused by a foreign substance, such as a blood clot or air bubble, that travels through the bloodstream and obstructs blood flow. The body’s organs and tissues need oxygen carried in the bloodstream to function and a disruption can cause impaired organ function or even failure. With the use of the ASDS, the risk of an embolism presents a serious complication.
Abbott issued the recall after receiving 16 injury reports with a direct link to its ASDS positioning device. In addition to these injuries, the company received another 10 incident reports related to the increased risk of air bubbles.
The FDA classified the Amplatzer Steerable Delivery Sheath recall as a Class 1 event. This is the most serious type of recall the agency issues. A stroke or cardiac embolism can potentially be life-threatening.
Heart Attack
An air embolism stemming from a cardiac catheterization that affects coronary circulation can lead to a heart attack. Cardiac catheterization is a medical procedure used to diagnose or treat some heart conditions.
Though small air embolisms have minimal clinical consequences, a large embolism can lead to myocardial infarction (heart attack), hemodynamic instability (unstable blood pressure, blood flow and oxygen delivery) and ventricular arrhythmia (a heart rhythm abnormality).
Heart Attack Facts:
A partially obstructed blood vessel can cause the body to develop blood clots.
Coronary thrombosis is a blocked artery in the heart that prevents blood flow to the cardiac muscle and lead to a heart attack.
Medical intervention for a heart attack depends on the severity of the event. Medications and procedures can break up the clot, while resuscitative measures can address failed or irregular heartbeat.
Stroke
The FDA also warns of the possibility of a stroke when using ASDS. A stroke occurs when there is an interruption or reduction in the supply of blood to the brain that causes cells to die. Strokes are medical emergencies, with early intervention critical for reducing brain damage and other complications.
The use of an ASDS increases the risk of a stroke because of the potential for inducing an air embolism. It’s possible for air to enter the arterial bed directly during a procedural use of ASDS.
In veins higher than the heart, higher atmospheric pressure can cause the air bubble to rise and cause a cerebral venous air embolism. This means a blood clot develops and potentially leads to hemorrhaging within the brain. This can lead to ischemia and infarction, where the blockage of a vein in the brain may result low oxygen and tissue damage.
Hypertension or Hypotension
In situations where the use of ASDS leads to an air embolism, the obstructions can impact the heart. When the heart works too hard it can lead to hypertension. Blood pressure that is too high increases the risk of a stroke.
Decreased cardiac output (the amount of blood pumped by the heart each minute) from a reaction to an embolism causes low blood pressure or hypotension. This results in reduced blood and oxygen supply to tissues, potentially leading to complications in different organs such as the heart, lungs, brain, and kidneys.
Pericardial Effusion
ASDS complications can include fluid build-up in the space around the heart, known as pericardial effusion. The risk is higher in procedures using a device like the ASDS to close large defects. Incomplete closure can lead to interrupted blood supply and fluid buildup. According to a report, this was the most common complication associated with insertion of this device, following air embolism.
Pericardial Effusion Key Facts
A pericardial effusion is the accumulation of excess fluid in the pericardium, the sac-like structure surrounding the heart.
A pericardial effusion can prevent the heart from pumping blood normally.
A procedure to drain fluid from around the heart may be required (pericardiocentesis).
A pericardial effusion impacts how the heart works. Left untreated, the fluid around the heart presses in on the heart and prevents it from expanding. This can prevent the heart from pumping blood effectively and result in heart failure.
You can also review your surgical notes and medical records. In most cases, surgeons will list the devices used in the surgery, along with their model numbers. The recalled device number is ASDS-14F-075.
What To Do if You Suffer Complications After Surgery
If you have any of the symptoms listed above after your catheter procedure, tell your doctor immediately. Since most symptoms of air embolism occur quickly during or after the procedure, your doctor will likely be monitoring you for complications.
After your surgery, inform your cardiologist if you experience chest pain, changes in your heartbeat or other unexplained symptoms. Keep all your medical records, receipts for treatment, surgical notes and any other documentation related to your surgery and complications.
The FDA encourages patients and medical providers to report problems to its MedWatch program.
Can I File a Lawsuit for Amplatzer Steerable Delivery Sheath Injuries?
However, Drugwatch’s legal partners are no longer accepting these cases, and we are unaware of lawyers who are still taking them. There have been no jury verdicts or settlements announced for this litigation.
If you want to pursue a lawsuit, you will need to search for a product liability lawyer with experience in medical device litigation. You can also contact your local bar association for potential referrals.
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“An air embolism occurs when a bubble of air enters the bloodstream and blocks blood flow, which can cause serious problems in organs like the heart, lungs or brain. This often happens as a complication from medical procedures.”
