FDA Medical Device Recalls (openFDA)
Ev3, Inc: Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree.
- Recall number
- Z-2169-2008
- Recalling firm
- Ev3, Inc
- Product
- Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended as a palliative treatment of malignant neoplasms in the biliary tree.
- Status
- Terminated
- Initiated
- 2008-04-22
- Posted
- 2008-08-26
- Terminated
- 2011-12-10
- Reason
- A Protege PS Biliary stent system was mislabeled. The mislabeling resulted in a 9 mm diameter, 60 mm length stent being labeled as a 6 mm x 60 mm stent.
- Root cause
- Employee error
- Action
- The single affected consignee was visited by an ev3 representative to verify the use of the device or exchange it for an unaffected device. Information recorded on an ev3 Device Reconciliation Form.
- Quantity
- 1
- Distribution
- Nationwide Distribution --- state of LA.
- Lot, serial or model codes
- Lot 2675311
- 510(k) numbers
- K032580
- 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
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
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 3e6df46828c1, published 2026-10-06