Events

Recall of Device Recall EndoGastric Solutions EsophyX2 Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endogastric Solutions Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65855
  • Event Risk Class
    Class 2
  • Event Number
    Z-1982-2013
  • Event Initiated Date
    2013-06-06
  • Event Date Posted
    2013-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120509
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
  • 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.
  • 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.

Device

Device Recall EndoGastric Solutions EsophyX2 Device
  • Model / Serial
    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.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed nationwide and Italy.
  • 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.
  • Manufacturer
    Endogastric Solutions Inc

Manufacturer

Endogastric Solutions Inc
  • Manufacturer Address
    Endogastric Solutions Inc, 8210 154th Ave NE, Redmond WA 98052-3877
  • Manufacturer Parent Company (2017)
    Endogastric Solutions Inc
  • Source
    USFDA