Alsius Cool Line Catheter, Model CL-2295AE recallZ-0503-2007 · Alsius Corporation · initiated Jan 1, 2007
Terminated All recalls posted in February 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alsius Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0503-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 1, 2007
- Posted by the FDA
- Feb 15, 2007
- Recalling firm
- Alsius Corporation
- Quantity
- 125
- Product code
- NCX
- FDA submissions
- K014241
- Distribution
- Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
Product description
Alsius Cool Line Catheter, Model CL-2295AE
Code information (models, lots, serial numbers)
Lot numbers: 16243 & 16292
Other devices under the same FDA submission
2 devices cleared under K014241 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Start-Up Kit CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling8 reports
- Start-Up Kit Custom Luer CG-500DZoll Circulation, Inc. · System, Hypothermia, Intravenous, Cooling1 death4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 37192).
- Z-0502-2007 · TerminatedAlsius Cool Line Catheter, Model CL-2295A
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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