The company identified the possibility that some Echelon Flex Endopath staplers may contain an out-of-specification anvil component within the jaw of the device. The issue could lead to malformed staples and compromised staple line integrity, which could in turn prolong surgery or cause postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention or death.
The company said that <1% of the devices from impacted lots could contain the improper anvil component. The devices that Ethicon recalled were distributed in Belgium, Denmark, France, Germany, Luxembourg, Switzerland and the Netherlands, according to an urgent field safety notice.
Ethicon has identified the cause of the issue and implemented corrective measures. The company also stopped shipments from the impacted lots, warning users of the product that the distribution dates for affected products were between August 1, 2019, and August 15, 2019.
Earlier this year, the FDA published an analysis of nearly 110,000 stapler incidents that have occurred since 2011. Among the incidents were 412 deaths, 11,181 serious injuries and 98,404 malfunctions. ECRI Institute said it has investigated 75 stapler incidents, including numerous fatalities, and published 42 safety alerts.
Shares of JNJ were down -0.3% at $132.81 per share in mid-afternoon trading today.