UNITED STATES – According to an online news article published by hitinfrastructure.com, Abbott has issued a recall of its Ellipse implantable cardioverter defibrillators (ICDs) after learning that electrical failures may prevent patients from receiving necessary and potentially life-saving treatment.
Ellipse implantable cardioverter defibrillators (ICDs) are used in patients with heart conditions, including slow heartbeat (bradycardia), fast heartbeat (tachycardia), and in cases when coordination is needed to treat heart failure. The Ellipse ICD is implanted under the skin in a patient’s upper chest and is connected to insulated wires, also known as “leads,” that are inserted into a patient’s heart.
Patient safety is dependent upon the proper function of the ICDs, and because Abbott has identified electrical failures associated with certain Ellipse ICDs, patients may be at risk of suffering injuries or death.
Abbott has learned that a faulty manufacturing process may have caused some aluminum wires to be exposed, which can lead to electrical shorting and prevent the flow of electricity to a patient. Without the flow of electricity to patients, the underlying heart condition may go untreated. Because Abbott is not able to determine which specific Ellipse ICDs have electrical failures, the company is recalling all ICDs.
Specific Recall Information
The United States Food and Drug Administration (FDA) has designated the Ellipse recall as “Class I.” A recall is only categorized as Class I when the medical device in question poses a serious risk of injury or death to patients and is considered the most serious recall category. Whenever a medical device company issues a recall, the FDA reviews the recall information and decides what classification should be afforded to the recalled medical device.
Additionally, the FDA provides specific recall details for patients and healthcare providers to ensure all information is being communicated to the medical community. The FDA has provided the following information on the Ellipse ICD recall:
- Product: Certain Ellipse Implantable Cardioverter Defibrillators
- Lot Numbers: All lots manufactured between April 5, 2019 and May 29, 2019
- Model Numbers: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, and CD2411-36Q
- Manufacturing Dates: April 5, 2019 to May 29, 2019
- Distribution Dates: May 6, 2019 to June 14, 2019
- Number of Devices Recalled in the US: 108
- Date Abbott Initiated the Recall: June 20, 2019
Luckily, there have been no reports of patient injuries or death. However, given the seriousness of the electrical failure identified by Abbott, the company felt it was necessary to recall the Ellipse ICDs to ensure no patient is harmed by the product going forward.