Becton, Dickinson And Company: Catheter, Flow Directed
Recall Summary Becton, Dickinson and Company is recalling Swan-Ganz Pacing Catheters (Model D200F7) worldwide because the blue proximal injectate lumen hub may leak or break due to manufacturing changes, potentially causing infection, medication loss, or blood loss. The catheters were distributed across the United States and internationally to numerous countries including Canada, Japan, Australia, and countries throughout Europe, the Middle East, and South America. This is a Class II recall, indicating a serious but not immediately life-threatening issue.
- Recalling firm
- Becton, Dickinson and Company
- Product
- Swan-Ganz Pacing Catheter, Models: D200F7;
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a0a2c6a5-c588-4ba1-8538-969a980858f6