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U.S. Department of Health and Human Services

Class 2 Device Recall SwanGanz Jr Catheter

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 Class 2 Device Recall SwanGanz Jr Cathetersee related information
Date Initiated by FirmApril 08, 2026
Date PostedMay 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2203-2026
Recall Event ID 98603
510(K)NumberK231248 
Product Classification Catheter, flow directed - Product Code DYG
ProductSwan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Code Information Model-UDI-DI(Expiration): SGPT755P/00690103219388/65869018(6/24/2026), 66010501(9/23/2026), 67122784(10/28/2027); SGPT54/00690103219289/65956343(8/19/2026); SGPT64P/00690103219371
FEI Number 3032916632
Recalling Firm/
Manufacturer		 Becton, Dickinson and Company
17200 Laguna Canyon Rd
Irvine CA 92618-5403
Manufacturer 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 2		Process change control
ActionOn 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 in Commerce183
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYG
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