Draeger’s ventilator sound insulation recall triggers FDA Class I notification

Dive Brief:

An issue with the sound insulation foam used in a Draeger ventilator could cause serious injury or death, the U.S. Food and Drug Administration warned in a Wednesday recall notice.
Draeger assessed the potential for the foam in its Carina Sub-Acute Care Ventilators to degrade. In some tests, the company found concentrations of a potentially carcinogenic component were at levels above the acceptable threshold in children.
The discovery led Draeger to send an urgent medical device recall notice to customers in June. Customers can continue to use the devices, under certain conditions, and Draeger plans to swap out the foam for another material in the fourth quarter.

Dive Insight:

The recall covers a different type of polyurethane than the material at the heart of Philips’ recall of sleep and respiratory devices. Philips recalled its devices over the potential for polyester-based polyurethane to break down. Draeger uses polyether polyurethane in its devices. Polyester and polyether are the two main types of polyurethane and have different properties.

However, there are similarities between the two cases. In both, foam used to insulate the sound of respiratory devices was found to expose people to materials with the potential to cause harm. Noting the risk of exposure to hazardous chemicals, toxic reactions and death, the FDA categorized Draeger’s notice as a Class I recall, its most serious type.

Draeger saw no age-related degradation when operating its Carina ventilators for up to 15 years, the company said in its recall notice to customers. However, standard tests showed concentrations of 1,3-Dichloropropan-2-ol, which is acutely toxic and potentially carcinogenic, exceeded the acceptable uptake level during continuous use in children.

No patients have reported symptoms of an acute toxic reaction or any other complaints, and Draeger has found the risk of additional cancer cases is low. Even so, the company is asking customers to only use the ventilators in adults and on certain settings associated with lower levels of the chemical for now.

Draeger has designed a new blower cover to replace the foam. The company plans to make the blower cover available in the fourth quarter and add it to ventilators free of charge. Draeger stopped making the Carina ventilators in 2019.