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EsophyX2 HD
ENDOGASTRIC SOLUTIONS, INC. · Model R2005 · UDI-DI 00810275011065
ODE
Prescription
1
510(k) clearances
359
Adverse events (2 deaths)
4
Recalls
11
Facilities
Description
EsophyX®2 HD Device with SerosaFuse Fasteners and Accessories
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-14 | Merit Medical Systems, Inc. | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| 2025-03-14 | Merit Medical Systems, Inc. | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. |
| 2013-06-06 | Endogastric Solutions Inc | 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, sur |
| 2013-02-04 | Endogastric Solutions Inc | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.