Z-0503-2007

Alsius Cool Line Catheter, Model CL-2295AE

Name: Z-0503-2007 Alsius Cool Line Catheter, Model CL-2295AE
Creator: Alsius Corporation
Published: 2007-01-01
License: https://open.fda.gov/license/

Alsius Corp. / initiated 2007-01-01 / Terminated

FDA source

Alsius Corporation began a recall of Alsius Cool Line Catheter, Model CL-2295AE on 2007-01-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0503-2007
Status: Terminated
Initiated: 2007-01-01
Posted: 2007-02-15
Terminated: 2007-06-22
Recalling firm: Alsius Corp.
Product: Alsius Cool Line Catheter, Model CL-2295AE
Product code: NCX System, Hypothermia, Intravenous, Cooling
Reason for recall: 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: Other
Action: 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.
Quantity in commerce: 125
Distribution: Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
Product codes and lots: Lot numbers: 16243 & 16292

Product code NCX

K014241Class IICoolgard 3000, Cooline, Start-Up, Models 3000, Cl-2085B, Cl-2295A, Cg-500DAlsius Corp. / cleared 2003-08-01

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)