Z-0935-05

ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No...

Name: Z-0935-05 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No...
Creator: Ev3
Published: 2005-06-10
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-06-10 / Terminated / root cause: labeling and UDI

FDA source

Ev3 began a recall of ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN... on 2005-06-10. The reason FDA records is "A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative". 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-0935-05
Status: Terminated
Initiated: 2005-06-10
Posted: 2005-06-25
Terminated: 2005-11-17
Recalling firm: Medtronic, Inc.
Product: ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: ev3 representative went to the 2 hospitals to retrieve affected product on 06/10/05, completed a Field Action Form and left a copy with the hospital.
Quantity in commerce: 1
Distribution: FL and PA
Product codes and lots: 1179167

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)