Z-2203-2026Class II

Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P

Name: Z-2203-2026 Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Creator: Becton, Dickinson and Company
Published: 2026-04-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2026-04-08 / Open, Classified / root cause: manufacturing process

FDA source

Becton, Dickinson and Company began a recall of Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P on 2026-04-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2203-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-08
Posted: 2026-05-15
Recalling firm: Becton Dickinson & Co
Product: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Product code: DYG Catheter, Flow Directed
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.
Root cause tag: manufacturing process
FDA 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 [email protected] Questions can be directed to the firm's Customer Service at (800) 424-3278
Quantity in commerce: 183
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2203-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2202-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-15
Z-2203-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-15
Z-2204-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-27	2026-05-15

Product code DYG

K231248Class IISwan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC / cleared 2023-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)