Recall Z-2203-2026 ยท DYG Catheter, Flow Directed
Becton, Dickinson and Company
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
| Date | May 15, 2026 (initiated Apr 8, 2026) |
| Status | Open, Classified |
| 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 |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform Edwards Lifesciencess, LLC, Sep 21, 2023 |