Class 2 Device Recall Medtronic Export XT

• Date Initiated by Firm: August 29, 2007
• Date Posted: October 31, 2007
• Recall Status: Terminated on September 08, 2008
• Recall Number: Z-0063-2008
• Recall Event ID: 44724
• 510(K)Number: K061958
• Product Classification: Aspiration Catheter - Product Code DQA
• Product: Medtronic Export XT Aspiration Catheter, 6F (US); Medtronic Export XT Aspiration Catheter, CE, 6FR (Outside US)
• Code Information: Al lot numbers
• Recalling Firm/ Manufacturer: Medtronic, Inc.; 35-37A Cherry Hill Drive; Danvers MA 01923-2565
• For Additional Information Contact: Fred Boucher; 978-777-0042
• Manufacturer Reason for Recall: Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.
• FDA Determined Cause: Labeling design
• Action: Medtronic has notifed sales representatives to visit Cath lab site with the letter dated August 29, 2007 and educate the user, provide the Safety Alert Letter and document delivery of the letter with the confirmation form.
• Quantity in Commerce: 13,940 units
• Distribution: Worldwide, including USA, Canada, India, Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and 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 = DQA and Original Applicant = MEDTRONIC VASCULAR