Recall Z-1982-2013 ยท ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Endogastric Solutions Inc
EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
| Date | Aug 17, 2013 (initiated Jun 6, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Endogastric sent the Safety Alert: EndoGastric Solutions (EGS), EsophyX2 Device letter, dated June 5, 2013, to their consignees. Endogastric sent the second letter URGENT: MEDICAL DEVICE RECALL EsophyX2, dated July 26, 2013. This letter advised customers that the firm is voluntarily recalling EsophyX2 Devices with SerosaFuse Implantable Fastener and Accessories (Models R2001 and R2002) manufactured before February 2012. Customers who have UN-EXPIRED devices in their inventory are advised to discontinue use and fill out the Medical Device Recall Return Response form and return it to Endogast |
| Quantity | 5192 units in the US and 41 units outside the US |
| Distribution | Distributed nationwide and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092400 | ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 Endogastric Solutions, Inc., Nov 6, 2009 |