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Alsius Corp.

United StatesFDA applicant, unverified

Devices
9
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Alsius Corp. makes

Alsius Corp. manufactures thermal regulation systems and associated catheter-based devices designed for controlled hypothermia and rewarming in medical procedures. Their portfolio includes systems like the ThermoGard and ThermoGard XP, which regulate patient temperature, alongside cooling and warming catheters such as the CoolGard 3000, CoolLine, Icy, and Fortius catheter kits. These devices are used in critical care, cardiac surgery, and neuroprotection applications to maintain precise body temperature during interventions.

The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Their products are listed in the FDA’s 510(k) registry, ensuring compliance with US medical device standards. Alsius Corp. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Alsius Corp., the earliest on 2004-06-21 and the most recent on 2007-01-01. By recorded status: 6 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2007

    • 1 Jan 2007 Z-0502-2007 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland Submission number: K014241
    • 1 Jan 2007 Z-0503-2007 Unclassified (pre-2012) Terminated 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. Distribution: Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland Submission number: K014241

  • 2005

    • 9 Nov 2005 Z-0369-06 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece,…
      Full distribution text Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malaysia, Italy, Ireland, Greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas, and United Kingdom
      Submission numbers: K014241, K030421
    • 25 Jul 2005 Z-1397-05 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece,…
      Full distribution text Nationwide and in Uruguay, Netherlands, Switzerland, Spain, Poland, China, Norway, Malasia, Italy, Ireland, greece, Germany, France, Finland, Canada, Belgium, Austria, Bahamas,
      Submission numbers: K014241, K030421

  • 2004

    • 10 Nov 2004 Z-0258-05 Unclassified (pre-2012) Terminated Product alarms that there may be a power supply interruption. Distribution: IL and NC. Specifically, Rush University Medical Center, Chicago IL and Duke University medical Center, Durham NC. Submission numbers: K014241, K030421
    • 21 Jun 2004 Z-1159-04 Unclassified (pre-2012) Terminated Higher than expected rate of pump alarms occur under specific conditions. Distribution: MA, PA, VA, FL, AL, MO, TX Submission numbers: K014241, K030421

Frequently asked questions

How many devices does Alsius Corp. have in the registry?

The registry currently lists 9 devices for Alsius Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Alsius Corp.'s devices?

Among its 9 most recently registered devices, Alsius Corp. has devices listed in FDA 510(k) (9 devices).

What risk classes do Alsius Corp.'s devices fall under?

Among its 9 most recently registered devices, the classes recorded for Alsius Corp.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Alsius Corp.?

FDA recall records list 6 recalls initiated by Alsius Corp., the most recent initiated on 1 Jan 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Alsius Corp. in the registry?

The most recently registered devices listed for Alsius Corp. include THERMOGARD THERMAL REGULATION SYSTEM, ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM, SOLEX CATHETER, MODEL SL2593 and THERMOGARD XP THERMAL REGULATION SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.