Z-1129-2008

ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan Lane North...

Name: Z-1129-2008 ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan Lane North...
Creator: Ev3, Inc
Published: 2008-01-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-01-18 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc began a recall of ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000. ev3... on 2008-01-18. The reason FDA records is "Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed". 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-1129-2008
Status: Terminated
Initiated: 2008-01-18
Posted: 2008-05-06
Terminated: 2008-11-04
Recalling firm: Medtronic, Inc.
Product: ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000. ev3 IntraStent LD Max Large Diameter Peripheral Stent Model Number: S18-16, Catalog Number: 90-2337-000 (not approved within USA).
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."
Quantity in commerce: 12
Distribution: Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Product codes and lots: Lot Numbers: 3766729 and 2417395

Product code FGE

K980290Class IIIti StentIntratherapeutics, Inc. / cleared 1998-07-21

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)