Endogastric Solutions

2 recalls •

• Categories: Other Medical Devices, Infusion Pumps

EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

Class I - Dangerous

Endogastric Solutions, Inc. has received a limited number of reports relating to the loss of tissue mold control when operating the R2001 or R2002 EsophyX2 device. In one case, surgical intervention was necessary to remove the device.

Jun 6, 2013 Other Medical Devices Nationwide View Details →

EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis

Class I - Dangerous

EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.

Feb 4, 2013 Infusion Pumps Nationwide View Details →