Z-0389-2007

ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120

Name: Z-0389-2007 ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120
Creator: Ev3, Inc
Published: 2006-12-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-12-06 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc began a recall of ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120 on 2006-12-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0389-2007
Status: Terminated
Initiated: 2006-12-06
Posted: 2007-02-01
Terminated: 2007-02-03
Recalling firm: Medtronic, Inc.
Product: ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 2
Distribution: IL, PA
Product codes and lots: Lot 1772812

Product code FGE

K033314Class IIProtege Gps Self-Expanding Nitinol Stent and Delivery SystemEv3, Inc. / cleared 2003-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)