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Endogastric Solutions Recalls
2 recalls on record · April 24, 2013 to August 28, 2013 · Medical Devices
August 28, 2013Medical DevicesFDA
Endogastric Solutions Inc recalls EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for th
Hazard: 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.
April 24, 2013Medical DevicesFDA
Endogastric Solutions Inc recalls EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in p
Hazard: EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.