Alsius CoolGuard 3000 Temperature Regulation System, Model… recallZ-1159-04 · Alsius Corporation · initiated Jun 21, 2004
Terminated All recalls posted in July 2004
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
Higher than expected rate of pump alarms occur under specific conditions.
FDA root cause category: Other
What the company is doing
Firm replaced circuit board having a new resistor. Recall is complete.
Recall details
- Recall number
- Z-1159-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 21, 2004
- Posted by the FDA
- Jul 23, 2004
- Recalling firm
- Alsius Corporation
- Quantity
- 15
- Product code
- NCX
- FDA submissions
- K014241, K030421
- Distribution
- MA, PA, VA, FL, AL, MO, TX
Product description
Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Code information (models, lots, serial numbers)
All codes.
Other devices under the same FDA submission
2 devices cleared under K014241, K030421 — 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
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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