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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-0937-06
Recall Event ID 35236
510(K)Number K021256  
Product Classification Catheter, Percutaneous - Product Code DQY
Product CATH. GUIDE 6F 3DRC LAUNCHER
CATHETER LA63DRC LA 6F 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:LA63DRC
Code Information Lot Numbers:  0000000809 0000001672 0000004368 0000006390 0000007945 0000008050 0000010416 0000013090 0000015793 0000016347 0000017343 0000018691 0000021080 0000021448 0000026961 0000027017 0000029272 0000030081 0000031545 0000032876 0000033004 0000033310 0000036791 0000039698 0000039701 0000042478 0000042480 0000042481 0000042483 0000043394 0000043395 0000043396 0000043397 0000044688 0000044689 0000044690 0000048190 0000049928 0000051656 0000052341 0000052342 0000052343 0000053298 0000057166 0000057173 0000058859 0000062625 0000062626 0000063814 0000064598 0000065941 0000066424 0000069821 0000069822 0000070752 0000070753 0000070754 0000070755 0000076277 0000076278 0000077240 0000077692 0000077693 0000077694 0000077726 0000077727 0000082847 0000083155 0000083460 0000089761 0000089762 0000090867 0000090868 0000090869 0000094144 0000094147 0000096672 0000096673 0000099898 0000099900 0000099901 0000099903 0000104825 0000106607 0000109528 0000111281 0000116808 0000117515 0000118403 0000122108 0000123725 0000124582 0000127448 0000129423 0000134331 0000134382 0000136176 0000140170 0000144911 0000149162 0000149984 0000153083 0000158058 0000158630 0000160729 0000163065 0000163648 0000169115 0000169137 0000169194 0000171540 0000178645 0000180218 0000183953 176747 177008 177984 180271 182355 182725 183045 184732 184733 185579 186556 187467 188470 200113 200814 201404 203595 203868 205243 205244 205245 205885 206253 208848 209114 211111 211806 214406 217670 218439 219212 220088 221485 222464 223282 224100 
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 3547 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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