The FDA has issued a critical announcement regarding the recall of certain Draeger ErgoStar Catheter Mounts. This action pertains to specific models that may present serious risks if continued in use. Clinical, quality, and regulatory teams must assess their inventory immediately and take decisive action to ensure patient safety.
What Changed?
Draeger has initiated a recall of four models of ErgoStar Catheter Mounts due to reports of cracks forming in the catheter hoses during use. The affected products include:
- MP01840 | ErgoStar CM 40 | UDI-DI: 04048675420736
- MP01845 | ErgoStar CM 45 | UDI-DI: 04048675420729
- MP01855 | ErgoStar CM 55 | UDI-DI: 04048675420729
- MP01860 | ErgoStar CM 60 | UDI-DI: 04048675420699
The FDA classified this recall as the most serious type, warning that the use of these catheter mounts could result in severe injury or death.
What Is the Risk?
Draeger disclosed that some catheter mounts may develop cracks that result in leakage during patient ventilation. While ventilators and anesthesia devices may compensate for these leaks depending on the pressure settings, uncontrolled leaks may restrict ventilation. This could lead to serious complications such as desaturation or hypoxia.
Despite this risk, Draeger confirmed that, as of November 17, 2025, no significant injuries or fatalities have been reported in connection with this issue.
Actions to Take
Immediate Steps
The FDA recommends that healthcare professionals immediately pull any unused affected catheter mounts from stock. Draeger advises customers to:
- Avoid using any of the identified ErgoStar catheter models (CM 40, CM 45, CM 55, and CM 60).
- Return unused stock to Draeger promptly.
- Replace any currently in-use affected products with comparable alternatives, such as the MP01850 ErgoStar CM 50. This alternative is not identical to the recalled mounts but is considered suitable for substitution when medically appropriate.
Notification and Reporting
Facilities using these devices must ensure that all relevant staff are notified of this recall. Further, if any customers have distributed the affected products to third parties, they should forward the recall notice without delay.
Healthcare professionals and consumers who experience adverse reactions or identify quality issues related to these devices are urged to file a report with the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. The recall is also listed in the FDA’s Medical Device Recall Database for review.
What Is the Purpose of This Product?
The ErgoStar Airway Connector is designed to transfer respiratory gases between a ventilator or anesthesia machine and a patient interface, such as an endotracheal tube or mask. Ensuring the safety and reliability of such critical connectors is essential, as leaks or malfunctions have the potential to compromise life-support systems.
Conclusion
The recall of Draeger ErgoStar catheter mounts underscores the importance of vigilance in medical device safety. Healthcare facilities should act quickly to remove affected products from use, replace them as needed, and ensure compliance with this urgent recall notice. The FDA and Draeger are committed to resolving these safety issues to protect both patients and healthcare providers.
Disclaimer
This content is provided for informational purposes only and is not a substitute for legal or regulatory advice. Healthcare providers should consult FDA and manufacturer communications for complete details on compliance and action steps.