FDA announces urgent chest drain recall

Editor's Note

The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing.

The drain is being recalled by maker Maquet Cardiovascular, LLC, due to concerns of serious infection following the recall of Nurse Assist LLC’s 0.9% sodium chloride irrigation USP and sterile water for irrigation USP in November 2023 due to sterility concerns. This is the most serious type of recall—a Class 1—indicating that the devices could cause serious injury or death. 

The Express Chest Drain (Model 4050-100N) is designed to collect blood from the patient’s pleural cavity or mediastinal area, to be reinfused following surgery or to help manage blood loss during surgery. The drain includes a pre-packaged 30mL sterile water syringe which is used to fill the air leak monitor chamber. This allows clinicians’ to detect air leaks during or after device set-up. If the chest drain is not kept in an upright position, water in the air leak monitor chamber could migrate to the drainage fluid collection chamber, potentially exposing patients to an infectious pathogen.

Although there are currently no reports of injury or death due to use of the device, the FDA warns that “use of the affected syringe may cause serious adverse health consequences, including local infection, abscess empyema, mediastinitis, pyothorax, sepsis and death.” For more information or concerns, U.S. customers can contact Maquet Cardiovascular, LLC Customer Support at (888) 943-8872 (press option 2).