FDA has categorized Johnson & Johnson unit Ethicon’s recall of its Echelon Flex Endopath staplers as a Class I event, the agency said Wednesday.
The agency put the recall of 8,256 devices in its highest-risk category after concluding the fault could cause serious injuries or death.
Ethicon had learned of seven serious injuries and one death related to the recalled products by the time it began pulling the devices from the market earlier this month.
The recall classification is just the latest sign of the agency's concern about the safety of surgical staplers.
In May, an FDA advisory panel backed plans to require premarket review of surgical staplers used in internal procedures. The regulatory change would move such staplers into Class II and add special controls to the class of products. FDA proposed the changes in light of the safety record of surgical staplers.
From 2011 to 2018, FDA received 412 reports of deaths and learned of 110,000 malfunctions linked to surgical staplers and staples for internal use. An analysis of some of the malfunction reports showed almost one-third of the reported faults related to malformed staples or staple lines, the same issue that triggered the Ethicon recall.
For J&J, the move by FDA comes after the agency earlier this year labeled recall of 92,000 circular staplers as a Class I event.
In this latest case, Ethicon wrote to customers who bought the surgical staplers at the start of October to warn them of an out-of-specification component that could malform staples. These malformed staples could cause a range of complications, from prolonged surgical procedures to death.
To mitigate the risks, Ethicon asked customers to check their stocks of Echelon Flex Endopath staplers and quarantine any devices affected by the recall. Ethicon wants customers to return 60mm staplers subject to the recall immediately. The J&J subsidiary will only provide replacements for recalled 60mm staplers if it receives the defective device by the end of the year.
Based on the death and serious injuries linked to the devices, FDA categorized the recall as its most serious type of product withdrawal.
The history of problems with surgical staplers led the nonprofit ECRI Institute to put the products at the top of its list of the top health technology hazards earlier this month. ECRI based its ranking on the rate at which staplers cause harm as a result of both user error, such as choosing the wrong size of staple, and device malfunction.