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All product recalls associated with Hansen Medical Inc.
Total Recalls
1000
Past Year
1000
Class I (Serious)
127
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air into the catheter with a risk of subsequent embolism.
The recall involves American Flame AF-4000 series fireplace gas valves installed in residential fireplaces made by twelve manufacturers under the following brand names: Pacific Energy, Travis Industries, CFM Corporation, Canadian Heating Products, Portland Willamette, Rasmussen, Chimeneas de Columbia, Twin Eagles, FDM, Inca Metals (Savannah Heating), Even Temp, and Valley Comfort. The valves were installed in some but not all fireplaces. Date codes included in the recall include 0622 through 0718. The gas valve model number is located on a label on the bottom of each gas valve. The date code is located above the label.
The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.