Z-1802-2010

Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing...

Name: Z-1802-2010 Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing...
Creator: Medtronic CardioVascular
Published: 2009-07-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-07-30 / Terminated / root cause: labeling and UDI

FDA source

Medtronic CardioVascular began a recall of Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by... on 2009-07-30. The reason FDA records is "Mislabeling-- The incorrect Instructions for use may have been included with this product". 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-1802-2010
Status: Terminated
Initiated: 2009-07-30
Posted: 2010-06-14
Terminated: 2011-01-31
Recalling firm: Medtronic, Inc.
Product: Medtronic Racer Biliary Stent System, Model number XD518YF, UPC code 00721902758164 in a box containing sterilized pouch with product, manufactured by Medtronic Vascular, Sunnyvale, CA. Medical device system consisting of a balloon-expandable intraluminal stent premounted onto the balloon of an over the wire delivery catheter. The system as two radiopaque markers on the inner member and positioned to each side of the stent, to aid in the placement of the stent during fluoroscopy. The system is compatible with labeled guidewires. The device is provided sterile and pyrogenic. It is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Mislabeling-- The incorrect Instructions for use may have been included with this product.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: The firm, Medtronic, Inc., sent an "URGENT- VOLUNTARY MEDICAL DEVICE RECALL" dated July 30, 2009, to custumers (Sales Representatives, to health care provider, patient, and risk manager, hospital administrator). The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to immediately segregate any Racer Biliary units from model number XD518YF (L#0000705315) in their possession to prevent inadvertent use. Medtronic, Inc., representative will contact the customer to review the labeling and retrieve the device should it be in their inventory. The customers are being ask to cooperate by providing the representative with access to the product. If you have any questions, please contact 707-566-1548.
Quantity in commerce: 13
Distribution: Worldwide distribution: USA and Greater China.
Product codes and lots: Lot number 0000705315, use by date April 4, 2010

Product code FGE

K032768Class IIMedtronic, Inc. Racer Biliary Stent System (Racer), Model Xd#yf(l)Medtronic Ave, Inc. / cleared 2003-10-09

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)