Recall Z-2204-2026

Reason for recall

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

FDA-determined cause: Process change control

Action taken

On 4/8/2026, mailed correction notices were mailed to customers and distributors who were informed of the following: Consider the following to reduce the potential for hub breakage issues. Minimize manipulation of proximal injectate hub and lumen. Pay frequent attention to the (blue) proximal injectate lumen for leakage or breakage, and exchange with another catheter if the issue is encountered. Modify existing clinical workflows to minimize flexing and stress of (blue) proximal injectate lumen. For example: o Securing the catheter lumens to an IV arm board to mitigate bending/flexing of the lumen(s) o Consider using the stopcock on white hub to allow for intermittent transducer pressure tubing changes without twisting white hub on Swan Ganz (blue) proximal injectate lumen. o Prevent CO-Set syringe and proximal injectate lumen from dangling/hanging without support. o Change to automated cardiac output models to mitigate device stress. Providers and institutions may choose to utilize transthoracic or transesophageal echocardiography in combination with techniques to monitor central venous pressure via a central venous catheter in patients in need of right ventricle monitoring and management. Converting to Acumen IQ / FloTrac sensor can provide continuous minimally invasive hemodynamic monitoring from the arterial line. Consider using ClearSight cuff for continuous non-invasive hemodynamic monitoring. Distributors should forward the correction notice to customers who have purchased the impacted product. Complete and return the acknowledgement form via email to SMB-FCAUSAPM@bd.com Questions can be directed to the firm's Customer Service at (800) 424-3278