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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Single Stage Venous Cannula

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  Class 2 Device Recall Medtronic, Single Stage Venous Cannula see related information
Date Initiated by Firm December 14, 2011
Date Posting Updated January 18, 2012
Recall Status1 Terminated 3 on May 22, 2014
Recall Number Z-0812-2012
Recall Event ID 60720
510(K)Number K845045  K022272  K842375  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic.
Model # 's
CB66112, CB66114, CB66116, CB66118, CB66120, CB66122, CB66124, CB66128, CB66130, CB66132, CB66134, CB66136, CB66140, CB66236, CB66240, CB67312, CB67314, CB67316, CB67318, CB67320, CB67512, CB67514, CB67516, CB67518, CB67520, CB67522, CB67524, CB67528, CB67530, CB67532, CB67534, CB67536, CB67540, CB67636, CB67640, CB68112, CB68114, CB68116, CB68118, CB68120, CB68122, CB68124, CB68126, CB68128, CB68130, CB68132, CB68134, CB68136, CB68138, CB68140, CB69312, CB69316, CB69320,CB69322, CB69324, CB69328, CB69331, CB69428.

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 # , , CB66112 CB66114 CB66116 CB66118 CB66120 CB66122

11813252 11843724 11827750 11843725 11813258 11584816, 11799778 11827756 11785647 11813251 11799807 11561410, 11785661 11785648 11760072 11799779 11754233 11538323, 11760079 11773439 11749844 11785671 11734973 11502622, 11734945 11710255 11710254 11734970 11710271 11452595, 11691759 11691748 11691757 11572754 11669004 11254883, 11613172 11681293 11681289 11561406 11655514 11182280, 11610933 11669018 11641156 11508900 11641162 11150759, 11599805 11599798 11584819 11493477 11627324 11091693, 11572780 11561382 11561388 11434967 11599813 10919617, 11561378 11538310 11502627 11264460 11528295 10856277, 11538313 11528250 11385846 11182276 11490554 10843209, 11411017 11452576 11276282 11173236 11315471 10820591, 11370812 11373266 11182290 11150770 11278706 10792650, 11361018 11370804 11091678 11137730 11241600 10773248, 11326455 11361014 11137732 11123865 11206047 10751519, 11264468 11326456 11123882 11103220 11193432 10721043, 11241591 11254866 11114391 11091684 11173268 10699666, 11231073 11182289 11080537 11069185 11137743 10691424, 11218584 11150779 11069195 11058824 11103236 10613562, 11193453 11137720 11058842 11050709 11108109 10514225, 11137754 11123863 11041173 11041174 11080547 10503899, 11123841 11114398 11028717 11016744 11069202 10487793, 11080539 11069197 10992835 10960981 11041175 10318730, 11058851 11050712 10980889 10923636 10992836 10278866, 11028715 11041172 10832387 10919615 10970848 10269102, 11016742 11028716 10820589 10856275 10960982 , 10980899 11016743 10806901 10843148 10945751 , 10945750 11007099 10792648 10832388 10919616 , 10923635 10992834 10783528 10820590 10856276 , 10919613 10980884 10773245 10806902 10832389 , 10867469 10970847 10699672 10783529 10792649 , 10843208 10960980 10691455 10773246 10773247 , 10832386 10919614 10602850 10751518 10738032 , 10820587 10878783 10569665 10729510 10729497 , 10783526 10856274 10559130 10699694 10721042 , 10729534 10820588 10552235 10691463 10699704 , 10691412 10806900 10542908 10613407 10691464 , 10683880 10792647 10521730 10593905 10683908 , 10674111 10783527 10514236 10577104 10664495 , 10652292 10773244 10503880 10569677 10631770 , 10631752 10751517 10468804 10552243 10621341 , 10593945 10699689 10460194 10526627 10593931 , 10559122 10691469 10443541 10521722 10552234 , 10542875 10683896 10426841 10494788 10542905 , 10514256 10593942 10383047 10468812 10526630 , 10503859 10584281 10380517 10460167 10514222 , 10479511 10569692 10373509 10443564 10494795 , 10480197 10543465 10297648 10420852 10487845 , 10443537 10521726 10278862 10406890 10468799 , 10297669 10503873 10269077 10403803 10460198 , 10232697 10494786 10261310 10397632 10443550 , 10185498 10479551 10395337 10340579 , 10460193 10318738 10318753 , 10451347 10297661 10282386 , 10443531 10289587 10269130 , 10435584 10278840 10261341 , 10426824 10215032 10191687 , 10318754 10189491 10186263 , 10297653 , 10289595 , 10278886 , 10269114 , 10261340 , 10189490 , , , , , , , CB66124 CB66128 CB66130 CB66132 CB66134 CB66136, 11827767 11627333 11773446 11799799 11827744 11799792, 11773419 11599767 11749845 11681291 11710269 11760052, 11760049 11326472 11710245 11668999 11681284 11572757, 11734956 11218598 11641155 11641159 11627296 11425915, 11710265 11182291 11627304 11627300 11452588 11276285, 11681302 11173246 11599769 11452587 11370813 11231093, 11669022 11154396 11547341 11338577 11315466 11123840, 11655492 11150767 11538311 11326447 11295324 11058807, 11641165 11058804 11361023 11295323 11241607 11041178, 11627311 11055669 11315461 11254872 11206081 10913654, 11613167 11050669 11264444 11206086 11154378 10856281, 11528290 11028718 11028719 11154399 11150748 10751522, 11349220 11007101 10980910 11150747 10945753 10577107, 11326462 10992837 10923637 11058847 10820595 10569700, 11298131 10945752 10674167 11041177 10631766 10542971, 11241610 10901167 10664513 11028720 1
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
763-526-6000
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
Labeling design
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 14,306
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 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 = DWF and Original Applicant = DLP, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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