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U.S. Department of Health and Human Services

Class 3 Device Recall Medtronic COMPLETE SE SelfExpanding Biliary Stent System

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  Class 3 Device Recall Medtronic COMPLETE SE SelfExpanding Biliary Stent System see related information
Date Initiated by Firm November 24, 2008
Date Posted March 18, 2009
Recall Status1 Terminated 3 on March 27, 2009
Recall Number Z-0642-2009
Recall Event ID 50476
510(K)Number K062264  
Product Classification Biliary catheter and accessories - Product Code FGE
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.
Code Information Lot #0000767722
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular
5355 Skylane Blvd
Santa Rosa CA 95403-1045
For Additional Information Contact
707-566-0111 Ext. 105
Manufacturer 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.
FDA Determined
Cause 2		 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.
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 VASCULAR
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