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.
This recall has been terminated (originally issued June 14, 2010).
- Company
- Medtronic Cardiovascular
- Recall Initiated
- July 30, 2009
- Posted
- June 14, 2010
- Terminated
- January 31, 2011
- Recall Number
- Z-1802-2010
- Quantity
- 13
- Firm Location
- Santa Rosa, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeling-- The incorrect Instructions for use may have been included with this product.
Distribution
Worldwide distribution: USA and Greater China.
Lot / Code Info
Lot number 0000705315, use by date April 4, 2010
Root Cause
Mixed-up of materials/components
Action Taken
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.