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.

Recall number

Z-1982-2013

Recalling firm

Endogastric Solutions Inc

Product

EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.

Status

Terminated

Initiated

2013-06-06

Posted

2013-08-17

Terminated

2014-04-09

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 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

5192 units in the US and 41 units outside the US

Distribution

Distributed nationwide and Italy.

Lot, serial or model codes

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.

510(k) numbers

["K092400"]

PMA numbers

not on file

Product code

ODE

Firm FEI

3005473391

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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