The Echelon Flex Endopath staplers are sterile, single patient use devices that cut and staple internal tissue. Ethicon is recalling these devices because some devices may contain an out of specification component within the jaw of the device, which could lead to malformed staples. If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death. As of October 3, 2019, 7 serious injuries and 1 death had been reported to Ethicon for affected product codes.
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