Johnson & Johnson’s Ethicon subsidiary recalled 8,256 Echelon Flex™ Endopath® surgical staplers in the U.S. due to a risk of serious injury or death.
Ethicon reported 7 serious injuries and 1 death linked to the recalled surgical staplers as of October 3, 2019.
The problem is that some staplers may contain an out-of-specification part in the jaw of the device, which could lead to malformed staples.
Ethicon warned about the potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.
The recall includes four different versions of the Echelon Flex Endopath stapler, with product codes EC60A, PCEE60A, PLEE60A and PSEE60A.
The staplers are used during surgery to cut and staple internal tissue. They can be used in open or in minimally-invasive surgeries, including gynecologic, urologic, thoracic, pediatric, and general surgeries, according to the FDA.
In March 2019, the FDA investigated over 41,000 stapler incidents since 2011. The incidents included 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.