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U.S. Department of Health and Human Services

Safety

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Boston Scientific ENTERYX Procedure Kits and Injector Single Packs

Audience: Surgeons, Gastroenterologists, other healthcare professionals, and patients

[Posted 10/17/2005] FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution. Physicians should stop injecting ENTERYX immediately and follow the manufacturer’s procedures for returning unused product. FDA also provided recommendations on avoiding future occurrences and advice for patients.

[October 14, 2005 - Preliminary Public Health Notification - FDA]
[October 17, 2005 - Advice for Patients - FDA]