FDA Medical Device Recalls (openFDA)
Ev3, Inc: Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
- Recall number
- Z-0442-06
- Recalling firm
- Ev3, Inc
- Product
- Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75
- Status
- Terminated
- Initiated
- 2005-08-01
- Posted
- 2006-01-25
- Terminated
- 2006-12-31
- Reason
- A Primus device was labeled as a BXB 35 09-37-75 but contained a BXB35 07-27-75 stent.
- Root cause
- Other
- Action
- Notification was sent to ev3 Territory Managers to have them contact their customer, have them remove affected product from their shelves and place them aside. TheTerritory Manager is responsible for retreiving affected product and returning it to ev3.
- Quantity
- 18 devices
- Distribution
- AL, AZ, FL, KS, LA, MS, NC, NE, NY, TX
- Lot, serial or model codes
- Lot no. 923291, 923290
- 510(k) numbers
- ["K043243"]
- 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