FDA Medical Device Recalls (openFDA)
Ev3: Biliary Stent System (6Fr 9mm x 30mm).
- Recall number
- Z-0008-05
- Recalling firm
- Ev3
- Product
- Biliary Stent System (6Fr 9mm x 30mm).
- Status
- Terminated
- Initiated
- 2004-09-01
- Posted
- 2004-10-05
- Terminated
- 2005-11-03
- Reason
- A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
- Root cause
- Other
- Action
- A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
- Quantity
- 5 systems
- Distribution
- South Carolina, North Carolina, and Texas.
- Lot, serial or model codes
- SERB65-09-30-120 (.035) (Biliary) LOT #: 257441
- 510(k) numbers
- ["K033314"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2183870
- Firm city
- Plymouth
- 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