EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
FDA Recall Z-1136-2013 · Posted 2013-04-17
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Recalling FirmEndogastric Solutions Inc
Recall StatusTerminated
Product CodeODE
Date Initiated2013-02-04
Date Terminated2013-07-02
Product Quantity190
Reason for Recall
EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
Firm Action
EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226.
For questions regarding this recall call 425-307-9200.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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