Becton, Dickinson and Company: Swan-Ganz Pacing Catheter, Models: D200F7;

Recall number

Z-2204-2026

Recalling firm

Becton, Dickinson and Company

Product

Swan-Ganz Pacing Catheter, Models: D200F7;

Status

Open, Classified

Initiated

2026-04-08

Posted

2026-05-15

Terminated

not on file

Reason

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.

Root cause

Process change control

Action

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

Quantity

53

Distribution

Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.

Lot, serial or model codes

Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)

510(k) numbers

["K233983"]

PMA numbers

not on file

Product code

DYG

Firm FEI

3032916632

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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