FDA Medical Device Recalls (openFDA)
Alsius Corporation: Alsius Cool Line Catheter, Model CL-2295AE
- Recall number
- Z-0503-2007
- Recalling firm
- Alsius Corporation
- Product
- Alsius Cool Line Catheter, Model CL-2295AE
- Status
- Terminated
- Initiated
- 2007-01-01
- Posted
- 2007-02-15
- Terminated
- 2007-06-22
- Reason
- 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.
- 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
- 125
- Distribution
- Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland
- Lot, serial or model codes
- Lot numbers: 16243 & 16292
- 510(k) numbers
- ["K014241"]
- PMA numbers
- not on file
- Product code
- NCX
- Firm FEI
- 3002922896
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28