Trokamed Sheath Instructions Update is Class 1: FDA

FDA says the Trokamed 11/26/2024 recall that updated instructions for its Mini PCNL sheath is Class 1. An agency notice says Trokamed recommended these actions:

• not to use the Mini PCNL sheath as a suction and irrigation device;
• temporarily remove the nephroscope from the shaft to clear it and flush out kidney stone fragments; and
• replace the instructions for use with updated instructions provided by the company.

The notice says the previous instructions did not clearly describe that the sheath was not to be used for suction and irrigation. “If the device is used for suction or irrigation, it could result in reduced outflow through the shaft due to blood, tissue, and kidney stone fragments, which may quickly build up pressure within the kidney that may lead to kidney rupture,” the notice says. FDA says Trokamed reported one death related to the issue.