Class 2 Device Recall EndoGastric Solutions EsophyX2 Device

• Date Initiated by Firm: June 06, 2013
• Date Posted: August 17, 2013
• Recall Status: Terminated on April 09, 2014
• Recall Number: Z-1982-2013
• Recall Event ID: 65855
• 510(K)Number: K092400
• Product Classification: Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
• Product: EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
• Code Information: UN-EXPIRED devices with Expiration dates (8/31/2013, 11/30/2013, 12/31/2013, and 1/31/2014) and following LOT numbers: 401132, 401147, 401152, 401156, 401159, 401167, 401207, 401214, 401219, 401220, 401225, 401227, 401230, 401233, 401236, 401246, 401248, 401251, 401257, 401258, 401259, 401267, 401269, 401271, 401274, and 401276. EXPIRED devices with Expired dates (1/31/2013, 2/28/2013, 3/31/2013 4/30/2013, 5/31/2013, 6/30/2013, and 7/31/2013) and following LOT numbers: 400923, 400927, 400934, 400937, 400940, 400943, 400949, 400961, 400963, 400973, 400976, 400979, 400980, 400981, 400984, 400986, 400992, 400994, 400997, 400998, 401004, 401005, 401009, 401012, 401016, 401017, 401024, 401026, 401029, 401056, 401058, 401059, 401060, 401061, 401062, 401063, 401065, 401072, 401074, 401076, 401079, 401084, 401085, 401092, 401094, 401107, 401114, 401115, 401121, 401129, and 401130.
• Recalling Firm/ Manufacturer: Endogastric Solutions Inc; 8210 154th Ave NE; Redmond WA 98052-3877
• For Additional Information Contact: Customer Service and Support; 425-307-9269
• Manufacturer 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.
• FDA Determined 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 Endogastric. The Customer Service will contact customers with instructions on how to return the product to the company. Customers who may have EXPIRED devices are advised to with their central supply departments to ensure all identified products have been removed from inventory and destroyed. They should fill out the Medical Device Recall Return Response form with the lot numbers and quantity destroyed and return the completed form to the firm. Customers can call the Customer Service and Support at 425-307-9269, Monday through Friday, 8:00AM to 5:00 PM, Pacific Time for questions. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 5192 units in the US and 41 units outside the US
• Distribution: Distributed nationwide and Italy.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ODE