Tytek Medical Recalls its PneumoDart-Pneumothorax Needle

Tytek Medical has recalled its PneumoDart-Pneumothorax Needle due to the risk of blocked needles, which is caused by the presence of adhesive from the assembly process. “If the needle is blocked, emergency treatment is delayed which can lead to heart or lung failure, or death,” a recall notice says. An affected device could cause an additional injury since diagnosing a lung injury may be complicated, it says, adding that if treatment is unsuccessful with the first needle, attempts to place another needle could cause further lung collapse. FDA says there has been one complaint and no reported injuries or deaths.

The needle is used to remove air that has become trapped in the pleural cavity during a life threatening event, such as trauma to the lung or a collapsed lung. The needle is used in emergency pre-hospital or hospital settings.