Becton, Dickinson And Company recalls Swan-Ganz Pacing Catheter

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.

Swan-Ganz Pacing Catheter, Models: D200F7;

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

• FDA enforcement recordOfficial FDA database entry for Z-2204-2026
• FDA 510(k) clearance · K233983The device's official FDA premarket clearance record
• FDA device classification · DYGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1240The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Becton, Dickinson and CompanySearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.