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.
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.”
