Z-0008-05

Biliary Stent System (6Fr 9mm x 30mm)

Name: Z-0008-05 Biliary Stent System (6Fr 9mm x 30mm)
Creator: Ev3
Published: 2004-09-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-09-01 / Terminated / root cause: packaging

FDA source

Ev3 began a recall of Biliary Stent System (6Fr 9mm x 30mm) on 2004-09-01. The reason FDA records is "A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0008-05
Status: Terminated
Initiated: 2004-09-01
Posted: 2004-10-05
Terminated: 2005-11-03
Recalling firm: Medtronic, Inc.
Product: Biliary Stent System (6Fr 9mm x 30mm).
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
Root cause tag: packaging
FDA root cause: Other
Action: A recall notification letter dated September 01, 2004 was sent to customers. Customers are to retain product until pick up by Ev3 sales representatives.
Quantity in commerce: 5 systems
Distribution: South Carolina, North Carolina, and Texas.
Product codes and lots: SERB65-09-30-120 (.035) (Biliary) LOT #: 257441

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)