Enteryx Recall
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific announces the voluntary recall of the Enteryx esophageal gastric reflux suppression device. "The action is being initiated based on the procedural injection technique and is not related to the device and effectiveness of the Enteryx product when properly implanted," the company explains in a Sept. 23 release. Patients who have been treated with Enteryx within the last 30 days should contact their physician for follow-up. Boston Scientific changed Enteryx's labeling to clarify the injection instructions in August 2004, following the death of an Enteryx recipient from a ruptured aorta (1"The Gray Sheet" Aug. 23, 2004, In Brief)...