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All product recalls associated with Alsius Corporation.
Total Recalls
5
Past Year
0
Class I (Serious)
0
Most Recent
Jan 2007
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.
Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.