FDA Medical Device Recalls (openFDA)
Ev3, Inc: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
- Recall number
- Z-0389-2007
- Recalling firm
- Ev3, Inc
- Product
- ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
- Status
- Terminated
- Initiated
- 2006-12-06
- Posted
- 2007-02-01
- Terminated
- 2007-02-03
- Reason
- Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
- Root cause
- Other
- Action
- Letter 12/06/2006. An ev3 representative visited the affected hospital to determine the status of the recalled device. If the device is unused, the representative is to retrieve the device for return to ev3. The representative is to complete the Device Recall Field Action Form, along with a hospital representative signature, and fax the completed form to ev3.
- Quantity
- 2
- Distribution
- IL, PA
- Lot, serial or model codes
- Lot 1772812
- 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