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Breathing System Filters Recall: Draeger Removes SafeStar and TwinStar Filters due to Risk of Misleading Carbon Dioxide (CO₂) Readings
The FDA is aware that Draeger has issued an updated Urgent Medical Device Recall Notification to recall the SafeStar and TwinStar filters due to the risk of misleading capnography (carbon dioxide) readings, which could result in health care providers administering unnecessary or harmful treatments based on incorrect waveform interpretations.
The use of these affected filters may cause serious adverse health consequences, including airway injury, delayed or incorrect treatment, brain injury, and death.
To date, there have been serious injuries reported due to the slow increase of CO2 curve when using the sampling port of the filter. There have been no reports of death related to this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Draeger Customer Success at 1-800-437-2437 (press 2, then 1), or via email at US-Medical@draeger.com.
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