FDA Class I Recall: Tytek Medical PneumoDart-Pneumothorax Needle

Feb. 26, 2020

Tytek Medical is recalling its PneumoDart-Pneumothorax Needle due to the risk of blocked needles. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.

Read more at HPN.

The blockage in the needles 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. An affected device may cause additional injury since the diagnosis of lung injury may be complicated. If treatment is unsuccessful with the first needle, healthcare providers may attempt to place another needle and could cause further lung collapse.

The TM-317 PneumoDart-Pneumothorax Needle is used to remove air that has become trapped in the pleural cavity during a life-threatening situation such as trauma to the lung or a collapsed lung. The needle is used in emergency pre-hospital or hospital settings.

FDA has the announcement