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FDA-Device2026-05-27Class IIPROCESSING DEFECT

Becton Dickinson Swan-Ganz Catheters recalled for proximal hub leak and break risk

Becton Dickinson
OTHERNationwide distribution

Becton Dickinson Swan-Ganz catheters recalled for leak risk

Certain Swan-Ganz catheters may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This defect can result in loss of medication, blood loss, or infection during use.

  • Check if your facility uses affected Swan-Ganz catheter models (131F7, 131F7P, 131F7J, 141F7, 151F7, and others listed in the recall).
  • Review the lot numbers and expiration dates provided in the FDA notice to identify affected units.
  • Do not use affected catheters; consult with Becton Dickinson or the FDA for guidance on replacement or return.
  • Contact your healthcare provider or hospital if a recalled catheter was already used on a patient.
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
589,223
Manufactured in
17200 Laguna Canyon Rd, Irvine, CA, United States
Products
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2202-2026

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