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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae

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 Class 2 Recall
Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae
see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0809-2012
Recall Event ID 60720
Premarket Notification
510(K) Number
K842375 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
Product Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae. Rx Only, Sterile EO, Nonpyrogenic. Model #'s 67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, 67532, 67534, 67636.67638, 67640, 67536,67540. 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 # 67512 67514 67516 67518 67520 2008120772 2008120764 2009010345 2011051400 2009010363 2009020928 2008120951 2009020657 2011051756 2009011014 200902C083 2009021206 2009030252 2011051991 2009011126 2009060940 2009040678 2009080996 201109C051 200901C098 2009070724 2009050310 2009101098 2011100296 2009030778 2009120921 200906C140 2009120922 2011100296 2009040979 2010012832 200907C100 2010012834 2009081545 2010012832 2009110266 201003C172 2009102294 2010022256 2010012833 2010071569 2009120020 2010081992 2010020287 201008C158 2009121491 2010092162 201003C174 2010092166 2010012907 2011010390 2010080882 2011021006 2010031058 201101C123 2010081016 2011030122 2010051219 2011030269 2010081842 2011040908 2010081240 201103C206 2010082373 2011050610 2010082375 2011051757 2011020786 2011051212 201009C127 2011021764 2011061006 2011010165 201102C150 201106C159 2011011198 2011030477 2011070129 201102C020 201103C062 2011080426 2011040442 2011080425 2011082100 2011050734 2011100955 201108C035 2011080608 2011091007 2011081061 2011091519 2011092182 67522 67524 67526 67528 67530 2008110263 200810C234 200811C068 2008110384 200810C036 2008110458 200810C235 2008120913 2008110459 2008110260 2008121122 2008110113 2009010206 200811C167 2008111129 200812C017 2008110329 2009020253 2008120952 200811C092 2009011127 2008111022 2009020798 2008121004 2008120226 2009020658 2008120542 2009030486 2009010207 2009030253 2009040679 200812C058 2009030780 2009010346 200903C042 2009041174 2009010165 2009041176 2009010356 2009040325 2009060247 2009011128 2009060483 2009011378 2009050313 2009061467 200901C060 2009061239 200901C094 2009050314 2009070536 2009020835 200908C105 200901C110 2009061501 200907C037 2009030779 2009090936 2009020659 2009070275 2009101099 200903C062 2009091614 2009030487 2009071391 2009111480 2009040680 2009100556 2009031078 200907C045 2010011382 2009041175 2009101682 2009040681 200907C083 2010022257 2009050311 2009110267 2009040682 2009101684 201003C173 2009060248 2009110958 2009040980 200911C044 2010061881 2009060482 200911C045 2009041177 2009121493 2010071761 2009071389 200912C167 200904C121 2010010294 2010081242 200907C030 2010012909 200904C134 2010012911 201008C047 2009080492 2010022259 2009050312 201003C101 2010101289 200908C141 2010061880 2009051002 2010040457 2010120667 2009100218 2010080941 200905C029 2010051417 2011012087 2009101680 2010091859 200905C085 2010061065 201103C023 2009101680 2010101802 2009060484 2010062719 2011041066 2009101681 2010121023 2009070537 201006C078 2011051401 200910C073 201101C033 2009071390 2010091185 2011060106 2009112101 2011021007 2009080493 201010C040 2011061594 200911C075 2011030336 200908C143 2010120035 2011062399 2009120163 2011030861 2009091615 2010121022 2011071825 2009121492 2011040909 2009100219 2011010393 2011100295 200912C079 2011041293 2009101683 2011011649 2010012908 2011050126 200910C013 2011030337 2010022258 2011050732 2009110268 2011041287 2010030381 2011061007 2009110959 2011061005 2010031059 2011061595 200911C080 2011070923 2010040456 201106C129 2009120164 2011082711 2010061680 2011070150 2009120923 2011090552 2010071872 2011070326 2009120923 2011100956 2010081353 2011072144 2010012910 2011102229 2010081995 2011072505 2010022260 2010082369 201108C041 2010022261 2010091521 2011092035 2010022262 2010091522 201109C095 2010031060 2010091523 201110R042 2010032956 2010092158 201003C054 201009C179 2010050410 2010120668 2010050857 2010121825 2010070079 2011010391 2010070339 2011011003 2010071510 2011011003 2010072159 201101C122 2010072161 2011031499 2010081993 2011031891 2010082370 2011040476 2010090508 2011041475 2010091183 201104C021 2010101488 2011050125 2010101807 2011051211 201010C034 2011051903 2010120356 201105C109 2010121579 2011060415 2011011387 201106C160 201101C034 2011070324 2011021185 2011070947 2011021533 2011080872 2011031176 2011081996 2011032571 201108C036 201103C024 2011090377 2011041067 2011091382 201104C067 2011100096 2011050127 2011100787 2011050733 2011101612 2011060414 2011061987 2011062117 201106C125 2011071554 2011080030 2011081508 2011082882 201108C096 2011090378 2011091022 2011100515 2011101023 67532 67534 67536 67540 67636 2008110460 2008110707 2008121169 2009011131 2009010358 2008111023 2008111130 2009010742 2009020642 2009011234 2008111255 2008120228 2009050316 2009041180 200901C090 2008120227 2009011130 2009051345 200907C035 2009020255 2008120739 2009020661 2009060942 2009081548 2009030782 2008120953 2009041179 2009061241 2009090685 2009040684 2009010347 200904C010 2009080998 2010010297 2009051005 2009011129 2009051004 2009081547 2010012915 2009060943 200901C059 2009070277 2009091617 201003C058 2009071064 2009020254 2009070539 2009101102 2010040366 2009080495 2009020660 2009080997 200910C008 2011032425 2009100557 2009030781 200908C144 2009120925 2011041473 2009101103 2009040065 2009101101 2009121494 2011070399 200910C150 2009040683 2009101685 2010012914 2011082527 2009110960 2009040981 200910C149 201001C011 2011091131 200912C088 2009041178 2009112102 2010022265 2010012916 2009050315 2010012913 2010031063 2010022266 2009050709 2010022264 2010081038 2010040368 2009051003 2010031062 2010082371 2010061283 2009060485 2010060085 2010090510 2010070377 2009060941 2010070755 2010091343 2010070646 2009061240 2010080653 2010101288 2010071762 2009070276 2010081090 201011C178 2010120860 2009070538 2010081843 2010121577 2010121823 2009071063 201008C048 2011010071 201012C099 200907C036 201008C170 2011011707 2011011005 2009080494 2010101490 2011040907 2011020545 2009081546 2010121824 2011051213 2011020787 200908C077 201101C125 2011061592 2011031498 200908C102 2011021005 2011070325 2011032424 2009090684 2011040439 2011081310 201103C207 2009091616 2011041937 2011082712 2011040149 200909C005 2011061511 2011090551 2011040263 200909C058 201106C130 2011101801 2011040761 2009100220 2011070528 2011041142 2009101100 2011081308 201104C032 2009110269 201108C040 2011051214 2009111481 2011091555 2011061593 2009120194 2011092181 2011070164 2009120195 2011100788 2011072330 200912C045 2011101613 2011080786 200912C165 2011101800 201109C054 2010012912 2011100095 2010020288 2010021566 2010021567 2010022263 2010030382 2010031061 2010032284 201003C099 201003C142 2010050693 2010051221 2010060086 2010062650 2010070648 2010071210 2010080196 2010080198 2010081996 2010090784 2010090976 2010091342 2010091861 2010092160 201010C031 2010120861 2010121158 2011010070 2011010301 2011011004 2011011282 201101C124 2011021377 201102C070 2011031894 201103C063 2011040148 2011040436 2011041065 2011041290 2011050518 2011051907 2011051974 2011060416 201106C198 2011070924 2011071359 2011080877 2011082218 201108C037 2011090231 2011092042 2011101020 2011102039 2011102299 201110R043 67638 67640 2009070278 2009120196 2009110961 2010012918 2010010298 2010070098 2010012643 2010081015 2010012917 2010121578 2010070378 2011062120 2010081017 2011100953 2010091864 201009C028 2010101290 2011011392 2011021186 2011041938 2011051758 2011091132 2011100954 201110R121
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 120,438
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 = DWF and Original Applicant = DLP, INC.
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