FDA Medical Device Recalls (openFDA)
St. Jude Medical / Daig Division: FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
- Recall number
- Z-0535-2007
- Recalling firm
- St. Jude Medical / Daig Division
- Product
- FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
- Status
- Terminated
- Initiated
- 2006-10-05
- Posted
- 2007-03-01
- Terminated
- 2007-05-25
- Reason
- Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
- Root cause
- Other
- Action
- The affected customers were notified on 10/5/06 by letter.
- Quantity
- 40 Units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number 1239904
- 510(k) numbers
- ["K964518"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2182269
- Firm city
- Minnetonka
- Firm state
- MN
- 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