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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 Medtronicsee related information
Date Initiated by FirmApril 05, 2006
Date PostedJune 01, 2006
Recall Status1 Terminated 3 on June 20, 2007
Recall NumberZ-0981-06
Recall Event ID 35236
510(K)NumberK023402 
Product Classification Catheter, Percutaneous - Product Code DQY
ProductCATH. GUIDE 8F 3DRC LAUNCHER CATHETER LA83DRC LA 8F 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 Number: LA83DRC
Code Information Lot Numbers:  0000004701 0000014620 0000021416 0000025411 0000029777 0000045286 0000055307 0000064166 0000068034 0000069020 0000073860 0000076117 0000076118 0000093491 0000097927 0000098637 0000105371 0000120165 0000124169 0000140820 0000158119 200877 208238 214166 219232 221749 223371 
FEI Number 1220452
Recalling Firm/
Manufacturer		 Medtronic, Inc.
35 -37A Cherry Hill Dr
Danvers MA 01923-2565
For Additional Information ContactFred Boucher
978-739-3116
Manufacturer Reason
for Recall		Potential for non-sterility due to loss of package integrity
FDA Determined
Cause 2		Other
ActionMedtronic 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 Commerce214 units
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = DQY
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