Abbott initiated a voluntary safety notice on Feb. 26 regarding its MitraClip delivery system.
Although the FDA classified the notice as a Class I recall, Abbott is not removing any products from commercial distribution. However, the company is requiring training for all implanting physicians.
Abbott said it had received nine medical device reports of malfunction involving the MitraClip delivery system, in which the user could not separate the implantable chip from the delivery system. As of Feb. 26, there were 3,534 devices on the market, including 1,288 in the U.S.
In each case, the operator did not return the delivery system’s arm positioner to the neutral position, which prevented the MitraClip from detaching. The issues led to surgeries to remove the delivery system or replace the mitral valve. One patient died of severe comorbidities following surgery.
The FDA approved the MitraClip delivery system in October 2013 to treat patients with degenerative mitral regurgitation. During the fourth quarter of 2015, worldwide sales of the MitraClip increased double digits.