Class 2 Device Recall

• Date Initiated by Firm: January 14, 2004
• Date Posted: February 10, 2004
• Recall Status: Terminated 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: 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