Medical device maker Ethicon is one of the two chief manufacturers of surgical staplers in the U.S. Surgical staplers are widely marketed and used as an alternative to manual sutures made by surgeons to close internal wounds, their greatest benefit being reducing a patient’s time in surgery. However, Ethicon and other stapler makers have long been dogged by reports that their products frequently malfunctioned, causing serious injury and even death to patients.
Now Ethicon has initiated a recall of more than 8,000 of its Echelon Flex Endopath staplers, announced by the U.S. Food and Drug Administration in October. The FDA has identified this as a Class I recall, which indicates the devices could cause life-threatening injuries or death. As of October 3, seven serious injuries and one death had been reported to Ethicon for the affected products.
The Echelon Flex Endopath staplers are designed for use on only one patient, in major or minimally invasive surgical procedures including gynecologic, urologic, thoracic, pediatric, and general surgeries. They were manufactured between July 18 and August 3, 2019, and distributed to healthcare providers between August 1 and September 26.