COOLGARD 3000, COOLINE, START-UP - 3000

510(k) K014241

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESU Traditional	NumberK014241	Date1 Aug 2003Cleared	StatusActive

6 recalls · FDA

2 recalls, same reason
- Terminated Z-0503-2007 FDA Unclassified (pre-2012) initiated 1 Jan 2007
- Terminated Z-0502-2007 FDA Unclassified (pre-2012) initiated 1 Jan 2007
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.
- Terminated Z-0369-06 FDA Unclassified (pre-2012) initiated 9 Nov 2005
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.
- Terminated Z-1397-05 FDA Unclassified (pre-2012) initiated 25 Jul 2005
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.
- Terminated Z-0258-05 FDA Unclassified (pre-2012) initiated 10 Nov 2004
Product alarms that there may be a power supply interruption.
- Terminated Z-1159-04 FDA Unclassified (pre-2012) initiated 21 Jun 2004
Higher than expected rate of pump alarms occur under specific conditions.

1 jurisdiction

United States — FDA 510(k) Active

510(k)