• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Export XT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Medtronic Export XT
see related information
Date Posted October 31, 2007
Recall Status1 Terminated on September 08, 2008
Recall Number Z-0063-2008
Recall Event ID 44724
Premarket Notification
510(K) Number
K061958 
Product Classification Oximeter - 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, Massachusetts 01923-2565
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQA and Original Applicant = MEDTRONIC VASCULAR
-
-