Boston Scientific Enteryx Device

On September 23, 2005, Boston Scientific Corporation issued a recall of all Boston Scientific Enteryx Device Procedure Kits from commercial distribution.

A Boston Scientific Enteryx device is a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter. The Enteryx device polymerizes into a spongy material shortly after injection and once injected cannot be removed.

The serious adverse events involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus. Transmural injections can potentially result in death or serious injury. Signs and symptoms of transmural injection can potentially include: chest pain, flu-like symptoms, pneumonia, atelectasis, reactive pneumonitis, mediastinitis, pneumo-mediastinum, reactive pleuritis, pleural effusion, pericardial effusion, syncopal episodes, and flank pain. Some cases of transmural injection were not recognized at the time of the procedure or during immediate follow-up; these occurred even though fluoroscopy was used throughout the procedure.

Recipients of an Enteryx injection from a Boston Scientific Enteryx device should visit a physician and seek out legal counsel if harm or injury resulted from the injection process.

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