Z-0829-06

IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North...

Name: Z-0829-06 IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North...
Creator: Ev3, Inc
Published: 2005-12-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-12-29 / Terminated / root cause: labeling and UDI

FDA source

Ev3, Inc began a recall of IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent... on 2005-12-29. The reason FDA records is "IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)". 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-0829-06
Status: Terminated
Initiated: 2005-12-29
Posted: 2006-05-03
Terminated: 2006-12-26
Recalling firm: Medtronic, Inc.
Product: IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: IntraStent product S15-36 (P/N 90-1341-02) lot 494428 was labeled as IntraStent product S15-26 (P/N 90-1341-001)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: On March 3, 2004, shipping personnel noted that IntraStent product S15-36, lot 494428, was labeled as IntraStent product S15-26. Six units from the lot were in distribution. On December 29, 2005, customers were sent a Field Action Form to record the number of used or available for return stents at their facility. The form instructs the customer to return the completed original form and any unused stents.
Quantity in commerce: 6 devices
Distribution: AR, GA, IN, MA, TN, and UT
Product codes and lots: Model S15-36, lot no. 494428

Product code FGE

K993904Class IIIntrastent Doublestrut LdIntratherapeutics, Inc. / cleared 2000-02-01

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)