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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm January 14, 2004
Date Posted February 10, 2004
Recall Status1 Terminated 3 on November 15, 2004
Recall Number Z-0523-04
Recall Event ID 28128
510(K)Number K932092  
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Medtronic SiteSeer 5 F Tight Radius 145 Pigtail
Cardiovascular Angiographic Catheter
Item Number: 5A0029
Code Information Lot Number: 160760 Expiration Date: 2006-12
Recalling Firm/
Manufacturer
Medtronic, Inc.
37a Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information Contact Fred Boucher R.A.C.
978-739-3116
Manufacturer Reason
for Recall
Catheter distal tip may separate
FDA Determined
Cause 2
Other
Action Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.
Quantity in Commerce 20 units
Distribution NC, WA
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 = DQO and Original Applicant = C.R. BARD, INC.
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