By Josh Beckerman 
 

The U.S. Food and Drug Administration has identified an Abbott Laboratories (ABT) June recall of certain Ellipse Implantable Cardioverter Defibrillators as a Class I recall.

The FDA said 108 devices were recalled in the U.S. because of a faulty manufacturing process that caused some wires to be partially exposed.

Abbott isn't aware of any reports of device failure in implanted devices, the FDA said.

 

Write to Josh Beckerman at josh.beckerman@wsj.com

 

(END) Dow Jones Newswires

August 05, 2019 19:26 ET (23:26 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.
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