The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
Draeger has issued a letter to affected customers recommending certain ErgoStar Catheter Mounts be removed from where they are used or sold, according to a medical device recall notice from the US Food and Drug Administration (FDA).Â
According to the notice, Draeger has 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 Nov 17, Draeger has not reported any serious injuries or deaths associated with this issue.
The affected products are:
| 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
According to the recall notice, customers should 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 Nov 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.
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.
Customers in the US with adverse reactions, quality problems, or questions about this recall should contact Draeger Customer Service at [email protected] or 1-800-437-2437 (press 2 at the prompt, then 1).
