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

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand: Becton, Dickinson and Company
Product: Swan-Ganz Pacing Catheter, Models: D200F7;
Reason / hazard: 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.
Classification: Class II
Status: Ongoing
Distribution / sold at: 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.
Recall initiated: 2026-04-08
Code info: Model-UDI-DI/Lot(Expiration): D200F7-00690103147315/66725358(7/2/2027)
Product quantity: 53
Voluntary mandated: Voluntary: Firm initiated
City: Irvine
State: CA
Country: United States
Event id: 98603