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FDA-Device2026-05-27Class IIPROCESSING DEFECT

Becton Dickinson Swan-Ganz Pacing Catheter recalled for hub leak and breakage risk

Becton Dickinson
OTHERNationwide distribution

Becton Dickinson Swan-Ganz catheter recalled for hub leak risk

Certain Swan-Ganz Pacing Catheters (Model D200F7) may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, medication loss, or blood loss during use.

  • Check if you have the affected model (D200F7, Lot 66725358, expiration 7/2/2027).
  • Do not use the catheter if you have the recalled lot.
  • Contact Becton Dickinson or your healthcare provider for instructions on replacement or safe disposal.
  • Report any injuries or complications to the FDA MedWatch program.
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.

Sold states
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.
Affected count
53
Manufactured in
17200 Laguna Canyon Rd, Irvine, CA, United States
Products
Swan-Ganz Pacing Catheter, Models: D200F7;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2204-2026

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