August 5, 2019 — 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 ICDs provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart. A patient may need an ICD if their heartbeat is too slow (bradycardia), too fast (tachycardia) or needs coordination to treat heart failure.
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 customers to provide an Abbott replacement device. The recall affects all lots manufactured between April 5 and May 29 of this year; this includes model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C and CD2411-36Q.
Abbott is not aware of any related reports of this failure occurring in any affected implanted devices. Of the 108 devices recalled in the U.S., 31 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.
Healthcare 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. Healthcare professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
For more information: www.cardiovascular.abbott/us/en/hcp/resources/product/advisories.html
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