Z-0642-2009

Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded...

Name: Z-0642-2009 Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded...
Creator: Medtronic Cardiovascular
Published: 2008-11-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-11-24 / Terminated / root cause: manufacturing process

FDA source

Medtronic Cardiovascular began a recall of Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8... on 2008-11-24. The reason FDA records is "Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0642-2009
Status: Terminated
Initiated: 2008-11-24
Posted: 2009-03-18
Terminated: 2009-03-27
Recalling firm: Medtronic, Inc.
Product: Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic sent a notification entitled "URGENT - VOLUNTARY MEDICAL DEVICE RECALL" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111.
Quantity in commerce: 23 units
Distribution: Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.
Product codes and lots: Lot #0000767722

Product code FGE

K062264Class IIComplete Se Self Expanding Biliary Stent SystemMedtronic Vascular / cleared 2007-11-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)