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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm April 05, 2006
Date Posted June 01, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall Number Z-0969-06
Recall Event ID 35236
510(K)Number K022764  
Product Classification Catheter, Percutaneous - Product Code DQY
Product CATH. GUIDE 7F 3DRCC LAUNCHER
CATHETER LA73DRC LA 7F 100CM 3DRC 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 Code: LA73DRC
Code Information Lot Numbers: 0000006813 0000009012 0000009040 0000015848 0000031930 0000043653 0000043655 0000055236 0000055686 0000060347 0000068443 0000068446 0000074855 0000074857 0000079601 0000081441 0000083822 0000091563 0000097895 0000101072 0000101074 0000105403 0000115013 0000117385 0000123711 0000133675 0000138054 0000144973 0000149842 0000153958 0000160711 0000170645 0000174447 0000175189 0000187845 181734 184271 185910 187134 188547 201685 203306 205597 207631 208906 211159 214999 216576 218842 219217 221352 
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 2		 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 416 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 and Original Applicant = MEDTRONIC VASCULAR
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