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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Venous Cannula

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 Class 2 Recall
Medtronic Venous Cannula
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0814-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K800178 
Product Classification Tubing, Pump, Cardiopulmonary Bypass - Product Code DWE
Product Custom Packs/ Kerkrade. Contain Medtronic Venous Cannula, Sterile EO. Model #'s C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601D, C390702A, C390802A, C390903A, C391001B, C391102F, C391104F, C391203A, C391203B, C392502A, C392503A, C410201D, C410407A, C410407B, C431601A, C391104B, C391104D, C390601E, C350103B, C490901B, S342603B. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Code Information Model #/ Lot # C330201C C330201D C330201E C330206B C342603A C350103B 201778990 201333560 205081295 201308440 204054606 201551424 202046133 205309658 203601818 202303911 202640160 205320345 203954482 202632898 203901734 205382559 204022437 202749853 203988245 205405093 205295088 204702221 204083070 205430380 205341343 204140301 205382558 205009633 C350106A C390101D C390203D C390406C C390409B C390601C 203386584 201756864 201271206 201089120 201333454 201254615 204702226 201905232 201301780 201503223 201467644 201293772 204814118 202008866 201350933 201649278 202740140 201323302 201446358 201762036 202949628 201585473 201567009 202025197 203360831 201699263 201930998 202369699 203745171 201764741 202012666 202561642 204288932 201927157 202165777 203310174 204311077 201983847 202831965 203863206 204311078 202147109 203040326 203974731 204981269 202338794 203176693 204285949 204311100 202607179 203824089 204359270 205191686 203031085 203989352 204772228 204311101 203280877 204083184 204942619 204311102 204140178 205058667 205402352 204524639 205198592 205505532 204878946 205502765 204981273 205090466 205167834 205260796 205284044 205322751 205389438 C390601D C390601E C390702A C390802A C390903A C391001B 201978568 204506615 201514769 201254604 201412703 201424864 203458279 204524638 201669440 201581163 201716502 203721546 204774490 201893277 201777104 203958431 204918792 202102480 202045021 204030513 205135410 202276601 203217589 204186594 205204813 203293858 203435712 204314702 205314074 203722121 203647848 204444206 205327511 203844438 203814643 205397133 203955760 203909330 204133788 203988762 204334538 204080477 204399838 204136158 204437462 204236435 204567894 204319619 204828993 204404301 204952274 204480662 205127283 205050557 205199773 205114489 205284050 205225609 205322756 C391102F C391104B C391104D C391104F C391203A C391203B 201260397 202335015 202648288 203814113 201592267 202335015 201316863 202721406 203912313 201779099 202564471 201328866 202956306 203989351 202031340 202648288 201354079 203435354 204315229 202201301 202629850 201582137 204486509 202721406 201685303 204703505 202956306 201767640 204976133 203212352 201923860 205135962 203457797 202018139 205284041 203703579 202147111 205357458 203829112 202338090 205455476 203958091 202607450 204005429 202832635 204133662 202978994 204339276 203218293 204421636 203420717 204642948 203657578 204796134 203824092 204943321 203966968 205059363 204038746 205113433 204080534 204323903 204424421 204501914 204921866 205014886 205114486 205291411 205459133 205512599 203824093 C392502A C392503A C410201D C410407A C410407B C431601A 204821370 204821369 201249841 201428181 205113428 205357187 205217073 204916548 201278746 201436433 205287910 205217281 201334984 201715753 205397136 201454169 201892654 205470270 201585444 201971522 205507854 201685309 202496001 201767422 202604823 201936374 203142177 202212131 203434662 202596479 203451447 202657601 203800302 202753829 204070146 202942379 204288401 203218561 204399839 203531683 204437258 203784895 204548389 203863203 204695802 203977359 204921862 204039082 204129083 204179722 204368226 204452404 204563923 204942617 205050810 205122774 205244751 205307931 205354349 205407856 202212132 C490901B S342603B 201748829 204426525 202689619 203819553 205086432 205203567
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Manufacturer Reason
for Recall
Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue.
Quantity in Commerce 6,851
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, and Yemen.
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 = DWE and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
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