Johnson & Johnson’s Ethicon medical device division has recalled a line of surgical staplers over concerns that a part within the jawed hinge of the device may cause staples to be formed improperly. The units are from the Echelon Flex Endopath line and come in a variety of lengths. Echelon Flex staplers are single-use devices and are used for stapling internal tissues, generally during minimally invasive procedures.
Malformed staples in these situations can lead to catastrophic results, and one patient has already died as a result of complications caused by the device. According to the FDA, a failure to recognize or address a faulty staple line can cause “prolonged surgery, postoperative connective (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.” In addition to the fatality blamed on an Echelon stapler, seven serious injuries have also been reported.
The FDA has classified the Ethicon Echelon Flex Endopath recall as a Class I recall. The Class I recall is the FDA’s most dire of warnings, indicating that continued use of the product could cause serious injury or death. The agency’s website has a detailed listing of the affected lots of Echelon staplers as well as images of the packages that contain recalled devices. Echelon staplers are packaged individually as well as a part of pre-packaged surgical trays, and both packages are displayed on the site for provider reference.
This is far from the first issue encountered by Ethicon over its devices. Concerns over Physiomesh surgical meshes led to those products being completely removed from the market while the company’s power morcellators met the same fate over claims they could spread as-yet undiagnosed uterine cancer throughout a woman’s abdomen during a hysterectomy or fibroid removal procedure.
