The FDA today labeled a select recall of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon’s Endo-Surgery endoscopic and non-endoscopic curved intraluminal staplers with adjustable height staples as Class I.
Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The affected staplers are designed for use in the gastrointestinal tract to create anastomoses during surgical procedures, according to an FDA release.
The company is recalling the devices after confirming uncut washers in the stapler and malformed staplers due to insufficient firing, which can compromise staple line integrity.
An internal investigation of Ethicon’s manufacturing process showed a shift in process that occurred in March 2018 and continued through March 8 this year, when the line was shut down, according to the release.
Use of a defective product can cause serious patient harm or death, the FDA said, adding that Ethicon has confirmed two serious injuries related to the issue.
Potential risks from misfired staplers include death, sepsis, leading, the need for permanent ostomy-bags, life-long nutritional and digestive issues, leaks in closures, additional surgeries, follow-up closures, antibiotics and the need for additional imaging studies.
The recall affects 92,496 Endo-Surgery endoscopic and non-endoscopic staplers with adjustable height staples with product codes CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A and ECS33A manufactured between March 6, 2018 and March 6, 2019 and distributed between March 15, 2018 and March 8, 2019.
Ethicon began notifying customers of the issue on April 11, instructing owners of the device to quarantine and return affected devices for replacements.
The FDA also provided general recommendations for surgeons using staplers to avoid possibly dangerous adverse events.
Last April, Ethicon released an urgent field safety notice recalling select Intraluminal Staplers distributed in the UK and Ireland over issues with the devices that may affect their performance during surgeries.
