Abbott Initiates Class I Recall of Amplatzer Steerable Delivery Sheath Due to Air Embolism Risk
Abbott, a globally recognized healthcare company, has announced a Class I recall of its Amplatzer Steerable Delivery Sheath, model ASDS-14F-075, due to an increased risk of air embolism. The FDA has designated this as a Class I recall, the most serious type of recall, indicating that the use of the device might result in severe injuries or even death.
Recalled Product Details
Product Name: Amplatzer Steerable Delivery Sheath
Model: ASDS-14F-075
Distribution Dates: October 4, 2022, to February 22, 2023
Devices Recalled in the U.S.: 672
Date Initiated by Firm: June 12, 2023
The Amplatzer Steerable Delivery Sheath is a specialized cardiac catheter that provides a pathway for catheter-based devices to reach the heart’s chambers. Its primary function is to deliver the Amplatzer Amulet Left Atrial Appendage Occluder.
Reason for Recall
The recall is necessitated by a heightened risk of air bubbles (air emboli) being introduced into patients undergoing procedures with this particular device. The consequences of air embolism can be severe, leading to various health risks, including:
- Sudden reduction in blood flow to the heart (indicated by ST elevation).
- Fast or slow heartbeat (tachycardia or bradycardia).
- Low blood pressure (hypotension).
- Lack of sufficient oxygen in the blood (desaturation).
- Serious health complications, including stroke and death.
Abbott has documented 26 incidents and 16 injuries, though no deaths have been directly linked to this issue.
Who May be Affected
The recall impacts the following:
- Patients undergoing cardiac catheterization procedures with the Abbott Steerable Delivery Sheath.
- Healthcare providers planning to utilize the Abbott Steerable Delivery Sheath for cardiac catheterization.
The potential damages caused by the defective Abbott Amplatzer Steerable Delivery Sheath, which has been recalled due to an increased risk of air embolism, can be both serious and far-reaching. These damages could include:
- Physical Health Complications:
- Sudden Reduction in Blood Flow to the Heart: Indicated by ST elevation, this can lead to acute cardiac issues.
- Heartbeat Irregularities: Including tachycardia (fast heartbeat) or bradycardia (slow heartbeat), which can cause discomfort and potentially lead to more serious heart conditions.
- Low Blood Pressure (Hypotension): This may result in dizziness, fainting, and can be life-threatening if not treated promptly.
- Lack of Sufficient Oxygen in the Blood (Desaturation): Leading to difficulty in breathing and potential long-term respiratory problems.
- Stroke: A severe condition that can lead to permanent disability or death.
- Death: In extreme cases, the introduction of air emboli could lead to fatal outcomes.
- Financial Damages:
- Medical Expenses: Including hospital stays, surgeries, medications, ongoing treatments, and rehabilitation costs related to the injuries caused by the defective product.
- Loss of Wages: If the affected individual is unable to work due to health complications, they may suffer a loss of income and future earning capacity.
- Emotional and Psychological Damages:
- Pain and Suffering: This encompasses physical pain and emotional distress, which can affect the overall quality of life.
- Anxiety and Stress: The trauma of undergoing a procedure with a defective medical device and dealing with subsequent health issues can lead to anxiety, depression, and other mental health challenges.
- Legal Damages:
- Potential lawsuits may also seek compensation for the harms listed above, holding the manufacturer accountable for releasing a product that could cause such significant issues.
The wide range of potential damages underscores the gravity of the recall and the importance of affected individuals seeking medical and legal counsel to understand their rights and options.
Recommended Actions
Abbott has proactively issued a Medical Device Recall notice to its customers on June 12, 2023. The notice highlights the following recommended actions:
- Returning all unused Amplatzer Steerable Delivery Sheaths to Abbott, with company representatives assisting in the return process.
- Using the fixed curve TorqVue 45°x45° delivery system for future implants of the Amplatzer Amulet Left Atrial Appendage Occluder.
- Completing and returning the acknowledgment form attached to the notice to Abbott.
Customers seeking additional information or assistance regarding this recall should contact their local Abbott representative or call Abbott Support at 1-800-544-1664 (Option 2).
The recall of the Amplatzer Steerable Delivery Sheath demonstrates Abbott’s commitment to patient safety and adherence to regulatory compliance. Both patients and healthcare providers are urged to comply with the recommended actions and to contact Abbott with any concerns or questions.
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