FDA Medical Device Recalls (openFDA)
St Jude Medical CRMD: CPS Valve Bypass Tool (VBT), Model 410192
- Recall number
- Z-1165-06
- Recalling firm
- St Jude Medical CRMD
- Product
- CPS Valve Bypass Tool (VBT), Model 410192
- Status
- Terminated
- Initiated
- 2006-06-01
- Posted
- 2006-06-24
- Terminated
- 2012-03-26
- Reason
- Sterility-Some of the sterile pouches in which these products are packaged may not have been properly sealed during their packaging process.
- Root cause
- Other
- Action
- The attached 'Dear Hospital Administrator' letter was sent out to our US sales representatives via FedEx on June 1, 2006. The sales representatives have been instructed to send back all of the devices in their inventory and to retrieve and return any remaining devices that were placed into hospital inventory. They are also instructed to deliver the attached 'Dear Hospital Administrator' letter to the appropriate person at each hospital where product is to be removed from the hospital shelf.
- Quantity
- 775
- Distribution
- Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
- Lot, serial or model codes
- All lots with a manufacturing date of May 30, 2006 or earlier
- 510(k) numbers
- ["K053217"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 2017865
- Firm city
- Sylmar
- 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