Z-1330-04

Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)

Name: Z-1330-04 Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)
Creator: Ev3
Published: 2004-07-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-07-09 / Terminated / root cause: labeling and UDI

FDA source

Ev3 began a recall of Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary) on 2004-07-09. The reason FDA records is "Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system...". 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-1330-04
Status: Terminated
Initiated: 2004-07-09
Posted: 2004-08-07
Terminated: 2006-12-28
Recalling firm: Medtronic, Inc.
Product: Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary)
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were labeled as 6Fr, 135 cm (.018').
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Send notification letter to direct accounts and an EV3 representative will contact the direct account within the next few days to arrrange for the return of all unused product.
Quantity in commerce: 11
Distribution: Eleven (11) devices were distributed to seven (7) U.S. customers. Ten (10) devices were distributed to seven (7) clinical study sites in the U.S.
Product codes and lots: Lot numbers: 257984, 257985, and 257986.

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)