The UK’s Medicines and Healthcare products Regulatory Agency issued an alert for Ethicon’s curved intraluminal staplers, warning of the risk of postoperative leaks, gastrointestinal tissue injury and bleeding.
The agency said the affected devices were manufactured since March 2018 with expiration dates in 2023. The problem was identified following increased complaints of malformed staples and returned devices from customers.
Ethicon is conducting a root cause investigation. The company said it expects the failure rate to remain below 0.1 percent.