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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Racer Biliary Stent System

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  Class 2 Device Recall Medtronic Racer Biliary Stent System see related information
Date Initiated by Firm July 30, 2009
Date Posted June 14, 2010
Recall Status1 Terminated 3 on January 31, 2011
Recall Number Z-1802-2010
Recall Event ID 53126
510(K)Number K032768  
Product Classification catheter, biliary, diagnostic - Product Code FGE
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.
Code Information Lot number 0000705315, use by date April 4, 2010
Recalling Firm/
Manufacturer		 Medtronic CardioVascular
3576 Unocal Pl
Santa Rosa CA 95403
For Additional Information Contact
707-566-1548
Manufacturer Reason
for Recall		 Mislabeling-- The incorrect Instructions for use may have been included with this product.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = MEDTRONIC AVE, INC.
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