Class I Recall of Abbott (Formerly St. Jude Medical Inc.), Ellipse Implantable Cardioverter Defibrillators
Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor. The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.
Abbott is aware of zero (0) related reports of this failure occurring in any affected implanted devices. Of the devices recalled in the US, 31 devices have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaint or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.
- Certain Ellipse Implantable Cardioverter Defibrillators
- Lot Numbers: All lots manufactured between April 5, 2019 - May 29, 2019
- Model Numbers: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q
- Manufacturing Dates: April 5, 2019 to May 29, 2019
- Distribution Dates: May 6, 2019 to June 14, 2019
- Devices Recalled in the U.S.: 108
- Date Initiated by Firm: June 20, 2019
On June 21, 2019, Abbott hand-delivered an Urgent Medical Device Recall letter to customers. The letter directed customers to take the following actions:
- Review the device model and serial numbers to identify the impacted patients and return the acknowledgement form to the sales representative.
- Device explant and replacement are recommended. Abbott will work with you to provide an Abbott replacement device.
Customers with questions about patient management or this recall, please contact Abbott Support at 1-800-727-7846 (select option #3), 8:30 AM – 5:30 PM (Central Time), Monday through Friday.
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
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