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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Export XT

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  Class 2 Device Recall Medtronic Export XT see related information
Date Initiated by Firm August 29, 2007
Date Posted October 31, 2007
Recall Status1 Terminated 3 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/
Medtronic, Inc.
35-37A Cherry Hill Drive
Danvers MA 01923-2565
For Additional Information Contact Fred Boucher
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 2
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