The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Names: Atrium Express Dry Suction Dry Seal Chest Drain
- Product Codes: CAC
- Model Numbers: 4000-100N and 4050-100N
- Distribution Dates: December 18, 2020, to November 8, 2023
- Devices Recalled in the U.S.: 251,142
- Date Initiated by Firm: December 11, 2023
The Express chest drains (models 4000-100N and 4050-100N) are disposable systems used to:
- Remove air and/or fluid from the chest cavity or mediastinum
- Help the lungs expand and improve breathing.
The Express Chest Drain (Model 4050-100N) facilitates collection of blood from the patient’s pleural cavity or mediastinal area for reinfusion after surgery or to manage blood loss from trauma.
Every Express chest drain comes with a pre-packaged 30mL sterile water syringe that is intended to be used to fill the air leak monitor chamber, allowing for the detection of air leaks during or after the initial device set-up, if desired.
Reason for Recall
Maquet Cardiovascular, LLC is recalling Atrium Express Dry Suction Dry Seal Chest Drain in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns.
If an Express chest drain is knocked over (device not kept in upright position), the water in the air leak monitor chamber could migrate from the air leak monitor chamber to the drainage fluid collection chamber. The patient could potentially be exposed to an infectious pathogen.
The use of the affected syringe may cause serious adverse health consequences, including local infection, abscess empyema, mediastinitis, pyothorax, sepsis and death.
There have been no reports of injury or death.
Who May be Affected
- Health care providers using Atrium Express Dry Suction Dry Seal Chest Drain
- People who receive care using Atrium Express Dry Suction Dry Seal Chest Drain
- Patients receiving an autotransfusion are at greater risk of infectious pathogen exposure because non-sterile water is mixed with the patient’s blood and reinfused back into the patient.
What to Do
On December 13, 2023, Maquet Cardiovascular, LLC sent all affected customers an Urgent Medical Device-Correction letter.
The letter requested customers to:
- Examine inventory and determine if any of the Atrium Express Dry Suction Dry Seal Chest Drains with the affected REF and LOT numbers are in their inventory.
- Forward the customer notification letter to the clinical area(s) of the facility where this product may be used/stored.
When used without the provided syringe, the Express chest drains are safe to use. If affected product is identified, customers can:
- Set up Express chest drain without water if visualization of active pneumothorax is not needed.
- Use a new syringe filled with sterile water instead of the provided one for intended use.
- Return affected Express chest drains to Getinge/Atrium Medical Corporation via Return Good Authorization (RGA).
Customers in the U.S. with questions about this recall should contact Maquet Cardiovascular, LLC Customer Support at (888) 943-8872 (press option 2).
- Medical Device Recall Database Entry
- Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
- Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada
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 using an online form, regular mail, or FAX.