Class 2 Device Recall Medtronic

• Date Initiated by Firm: April 05, 2006
• Date Posted: June 01, 2006
• Recall Status: Terminated on June 20, 2007
• Recall Number: Z-0949-06
• Recall Event ID: 35236
• 510(K)Number: K021256
• Product Classification: Catheter, Percutaneous - Product Code DQY
• Product: CATH.GUIDE 6F JL 4.0 SH 110CM CATHETER LA6JL40SHA LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40SHA
• Code Information: Lot Numbers: 0000099411
• Recalling Firm/ Manufacturer: Medtronic, Inc.; 35 -37A Cherry Hill Dr; Danvers MA 01923-2565
• For Additional Information Contact: Fred Boucher ; 978-739-3116
• Manufacturer Reason for Recall: Potential for non-sterility due to loss of package integrity
• FDA Determined Cause: Other
• Action: Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form.
• Quantity in Commerce: 22 units
• Distribution: Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK.
• 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 = DQY