Boston Scientific Corp. said it is recalling Enteryx, an endoscopic product used to treat acid-reflux disease, because of what it called doctor errors that have harmed several patients and killed at least one.
The company said is the recall is "not related to the safety and effectiveness of the Enteryx product when properly implanted." Enteryx is an injectable polymer used to fill the walls of the esophagus; it is supposed to block acid from flowing upward from the stomach.
In 11 cases, doctors accidentally punctured the wall of the esophagus while doing the procedure, causing serious complications including one death.
The recall was initially reported the The Wall Street Journal. It is posted on an obscure section of the company's Web site aimed at doctors.
"This action is being initiated based on the procedural injection technique and is not related to the safety and effectiveness of the Enteryx product when properly implanted. The Company has not found any evidence of complications resulting from long-term implantation of Enteryx," the company statement said.
Boston Scientific said it has informed the FDA of its actions and is notifying doctors and hospitals directly.
"The company has been collecting and analyzing a growing body of data that indicates procedural injection technique is critical to achieving clinically acceptable results. There have been a limited number of injections through the wall of the esophagus that were undetected at the time of the procedure and resulted in adverse events," the company said.