Tytek Medical issued a recall for its PneumoDart pneumothorax needles for air removal during life-threatening situations like lung trauma or collapse.
According to an FDA news release, the recall, which Tytek Medical initiated on Nov. 18, 2019, is now considered a Class I recall, the most serious kind.
The PneumoDart needle is designed to remove air that has become trapped in the pleural cavity during one of those life-threatening situations in emergency pre-hospital or hospital settings.
Tytek Medical recalled the PneumoDart due to a risk of blocked needles caused by the presence of adhesive from the assembly process. If the needle is blocked, emergency treatment is delayed, which can lead to heart failure, lung failure and/or death.
An affected device could also cause additional injury and if the first treatment is unsuccessful, health care providers may attempt to place another needle, potentially causing further lung collapse. Tytek Medical has received one complaint and no reported injuries or deaths.
The initial recall from Tytek in November of last year instructed customers to not use the affected product, which was manufactured and distributed between June 3, 2019 and Sept. 17, 2019. According to the FDA release, 920 devices have been recalled in the U.S. so far.