Abbott Recalls Ellipse Implantable Cardioverter Defibrillators (ICDs) After Learning Exposed Wires May Cause Product Failure
UNITED STATES – As reported in an online news article published by hitinfrastructure.com, Abbott, a drug and medical device manufacturer, has issued a recall of its Ellipse implantable cardioverter defibrillators, citing electrical failures and exposed wiring that may prevent necessary high voltage treatment to patients.
The Ellipse implantable cardioverter defibrillators (ICDs) are used to treat certain heart conditions. The ICDs are implanted under the skin in the upper chest with connecting insulated wires (“leads”) that go into the patient’s heart. A patient may be a candidate for the Ellipse ICD if the patient has bradycardia (slow heartbeat), tachycardia (fast heartbeat), or if coordination is needed to treat heart failure.
Abbott has identified electrical failures with the Ellipse ICDs that may pose a risk of harm to patients. Specifically, a faulty manufacturing process caused some aluminum wires to be partially exposed, potentially resulting in electrical shorting of the capacitor (a component that stores energy). Such electrical shorting may prevent the Ellipse ICD to deliver high voltage therapy to patients, posing a risk of serious injury or death. Additionally, there is no way to determine which Ellipse ICD devices will ultimately fail because of a faulty wiring issue. As such, Abbott has issued a full recall of all Ellipse ICDs.
The United States Food and Drug Administration (FDA) has classified the Ellipse recall as “Class I,” the most serious recall available for medical devices – a classification that is only used when a medical device has the potential to cause serious injuries or death. The FDA’s statement provides the following recall information for the Ellipse ICDs:
- 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
While there have been no reports of serious injuries or death, there have been enough reports to indicate that the Ellipse ICDs have the potential to fail, and such failure may place patients at risk.
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