A MedWatch Safety Alert was added to the FDA Medical Device Recalls webpage.
TOPIC: ECHELON FLEX ENDOPATH Staplers by Ethicon: Class I Recall - Due to Failure to Completely Form Staples
AUDIENCE: Surgery, Health Professional, Risk Manager
ISSUE: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
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