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.
Affected Product
The FDA is aware that Draeger has issued a letter to affected customers recommending certain ErgoStar Catheter Mounts be removed from where they are used or sold:
Part Number |
Designation |
UDI-DI |
|
MP01840 |
ErgoStar CM 40 |
04048675420736 |
|
MP01845 |
ErgoStar CM 45 |
04048675420729 |
|
MP01855 |
ErgoStar CM 55 |
04048675420729 |
|
MP01860 
|
ErgoStar CM 60 |
04048675420699 |
What to Do
Do not use any unused affected product. Unused stock should be removed and returned to Draeger. FDA recommends replacing currently in use affected product with a comparable alternative when available and medically appropriate.
On November 10, Draeger sent all affected customers a letter recommending the following actions:
- Do not use any ErgoStar CM 40, CM 45, CM 55, or CM 60 stock.
- Remove unused stock and return to Draeger.
- Draeger recommends using the alternative product MP01850 ErgoStar CM 50 as a replacement. This is not an identical item, but a comparable alternative.
- Ensure all potential users in your facility are made aware of this Urgent Medical Device Recall Notice.
- If you have forwarded affected products to third parties, please also forward this Urgent Medical Device Recall Notice.
Reason for Alert
Draeger stated that they have become aware of cases in which cracks have formed in the hose of specific ErgoStar catheter mounts. If these cracks form during use, leakage will occur. Depending on the size of the leakage and the selected ventilation pressure, the ventilator/anesthesia device can compensate for this. If the leakage cannot be compensated for, ventilation is restricted and may lead to desaturation or hypoxia for the patient.
As of November 17, 2025, Draeger has not reported any serious injuries or deaths associated with this issue.
Device Use
The ErgoStar Airway Connector conducts respiratory gases between the breathing system and the patient interface (such as an endotracheal tube mask) of a mechanically ventilated patient.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Draeger Customer Service at US-Medical@draeger.com or 1-800-437-2437 (press 2 at the prompt, then 1).
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
