Z-0863-03

Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

Name: Z-0863-03 Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
Creator: ev3, Inc.
Published: 2003-04-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-04-15 / Terminated / root cause: labeling and UDI

FDA source

ev3, Inc. began a recall of Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135 on 2003-04-15. The reason FDA records is "The label had an expiration date of August 2005, but the correct expiration date was February 2005". 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-0863-03
Status: Terminated
Initiated: 2003-04-15
Posted: 2003-05-22
Terminated: 2004-07-02
Recalling firm: Medtronic, Inc.
Product: Protg Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The label had an expiration date of August 2005, but the correct expiration date was February 2005.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Device Recall letter dated April 15, 2003 requested that the consignees hold the product for retrieval by the firm's representatives.
Quantity in commerce: 15 units
Distribution: Nationwide in United States.
Product codes and lots: Lot Number 132612

Product code FGE

K023243Class IIModification to Protege Self-Expanding Nitinol Stent with Starport Delivery TechnologySulzer Intratherapeutics, Inc. / cleared 2002-12-13

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)