November 1, 2019 — Ethicon has issued a Class 1 recall for Echelon Flex™ Endopath® Staplers due to a risk of serious injury or death.
The staplers may fail to completely form staples due to an out-of-specification part in the jaw of the device. The problem has resulted in 7 serious injuries and 1 death as of October 3, 2019, Ethicon reported.
Ethicon warned about the risk of death and life-threatening injuries, including longer surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention.
The recall involves four different versions of the stapler, with the product codes EC60A, PCEE60A, PLEE60A and PSEE60A. Approximately 8,256 devices in the U.S. are affected by the recall. The devices were distributed from August 1 to September 26, 2019.
The staplers can cut and staple internal tissue during open or minimally-invasive surgeries, including gynecologic, urologic, thoracic, pediatric, and general surgeries.
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