Alsius Corporation Alsius Cool Line Catheter, Model CL-2295A Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alsius Cool Line Catheter, Model CL-2295A
Brand
Alsius Corporation
Lot Codes / Batch Numbers
Lot numbers: 16174
Products Sold
Lot numbers: 16174
Alsius Corporation is recalling Alsius Cool Line Catheter, Model CL-2295A due to Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capac. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026