EndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss
EndoGastric Solutions is recalling EsophyX2 devices because of reports of loss of tissue mold control, which required surgical removal in one case.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device where surgical intervention was necessary to remove the device, meeting the rubric criteria for 'significant injury' or 'structural vehicle defect' equivalent in medical devices (Class II with significant adverse events).
Plain-English summary
EndoGastric Solutions, Inc. is recalling the EsophyX2 Device with Serosa Fastener and Accessories, Models R2001 and R2002. These devices are indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. The recall covers 5,192 units in the US and 41 units outside the US, distributed nationwide and in Italy.
The recall was initiated after the company received a limited number of reports regarding the loss of tissue mold control when operating the R2001 or R2002 devices. In one reported case, surgical intervention was necessary to remove the device.
The affected units include both unexpired and expired devices with specific expiration dates and lot numbers listed in the official recall notice. Users of these devices should contact EndoGastric Solutions or their healthcare provider for instructions on how to proceed.
The recalled product
- Product
- 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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