EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of sy...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1982-2013.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1982-2013.
Recall terminated by FDA.
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- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1982-2013.
Endogastric Solutions Inc
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Endogastric Solutions Inc Recall FAQ
Endogastric Solutions Inc is the subject of a medical devices safety report: EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of sy.... The notice was published on June 6, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 5,192 units are potentially affected.