Recall Z-1982-2013— Endogastric Solutions Inc
Class II · Terminated
Class II FDA medical device recall by Endogastric Solutions Inc, initiated 2013-06-06, terminated 2014-04-09. It names one FDA 510(k) clearance: K092400. Product: EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.. Reason: 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..
- Recalling firm
- Endogastric Solutions Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-06
- Terminated
- 2014-04-09
- Firm location
- Redmond, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.