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Endogastric Solutions Inc recalls EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for th
Recalled August 28, 2013 · FDA recall Z-1982-2013 · Endogastric Solutions
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. · FDA Class II
Units
5192 units in the US and 41 units outside the US
Sold at
Distributed nationwide and Italy.
Description
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.
Product
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Manufacturer(s)
Endogastric Solutions Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →