Z-1159-04

Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000

Name: Z-1159-04 Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Creator: Alsius Corporation
Published: 2004-06-21
License: https://open.fda.gov/license/

Alsius Corp. / initiated 2004-06-21 / Terminated

FDA source

Alsius Corporation began a recall of Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 on 2004-06-21. The reason FDA records is "Higher than expected rate of pump alarms occur under specific conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1159-04
Status: Terminated
Initiated: 2004-06-21
Posted: 2004-07-23
Terminated: 2004-12-02
Recalling firm: Alsius Corp.
Product: Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000
Product code: NCX System, Hypothermia, Intravenous, Cooling
Reason for recall: Higher than expected rate of pump alarms occur under specific conditions.
FDA root cause: Other
Action: Firm replaced circuit board having a new resistor. Recall is complete.
Quantity in commerce: 15
Distribution: MA, PA, VA, FL, AL, MO, TX
Product codes and lots: All codes.

Product code NCX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)