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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae

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  Class 2 Device Recall Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae 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-0810-2012
Recall Event ID 60720
510(K)Number K022272  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae.

Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s
68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 68132, 68134, 68136, 68138, 68140.

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 3 2009121500 2010120012, 2010101409 2011060943 2009121718 2010120132, 2010101780 2011070970 2010012919 201012C083, 201010C036 2011071095 2010022270 2011020052, 201010C037 2011100259 2010022271 2011020335, 2010110956 2011101779 2010022272 2011021781, 2010111147 201110R045 2010030383 2011022032, 201011C192 2010031066 2011031036, 2011010048 2010031067 2011031822, 2011010757 2010031068 2011032526, 2011020882 2010031069 2011040192, 2011030055 2010050494 2011050903, 2011040179 2010060924 2011050975, 2011041051 2010070343 2011050976, 2011051406 2010070359 2011050977, 2011060488 2010070596 2011061105, 2011060724 2010080930 201106C131, 201107C056 2010080972 2011070133, 2011080376 2010090838 2011070347, 2011082054 2010091331 201107C099, 201108C173 2010091809 2011080659, 2011090557 2010092648 201108C133, 2011090584 2010101478 2011090960, 2011091875 201010C038 2011091283, 201109C028 2010110534 2011100535, 2011100127 2010111453 2011101078, 201011C086 2011101461, 2010121564 , 2011010049 , 2011010493 , 2011011472 , 201101C081 , 2011021353 , 201102C151 , 2011031033 , 2011031454 , 2011040180 , 2011040190 , 2011040582 , 2011041598 , 2011051027 , 2011051027 , 2011051027 , 2011060785 , 2011060941 , 2011060942 , 2011070538 , 2011072227 , 201107C057 , 2011080639 , 201108C132 , 2011090264 , 2011091282 , 2011100987 , 2011102100 , 2011102791 , , , , , , 68132 68134 68136 68138 68140, 200808C112 2008121124 2008120663 2009030873 2009021164, 2008110567 2009010028 2008120737 2009070280 2009050711, 2008111025 2009010214 200812C088 2009070400 2009070619, 2008120230 2009010354 2009011200 2009110968 2009071072, 2008120399 2009011016 2009020933 2010080520 2009120931, 2008120661 2009011390 2009021128 2010082062 2010031076, 2008120662 200901C086 2009060253 2010090955 2010032288, 2008121182 2009030489 2009061245 2011020953 2010070157, 2009010212 2009040070 2009061504 2011030170 2010101305, 2009010213 2009050056 2009071071 201103C142 2010120619, 2009011389 2009050321 2009071399 2011090566, 2009020662 2009060949 2009101109 2011090585, 2009030783 2009061244 2009110276 , 2009040068 2009070279 2009110967, 2009040069 2009071070 2009120213, 2009041184 2009071398 2010012904, 2009051008 2009080511 2010020291, 2009051348 2009081551 2010022278, 2009060252 2009090688 2010031075, 2009060550 2009100224 2010032960, 2009060948 2009101108 2010071547, 2009061243 2009110275 2010100119, 2009070542 2009120930 2010110957, 2009071068 2009121503 2010120011, 2009071069 2010010304 2011011474, 200907C043 2010012923 2011021897, 200907R017 2010022277 2011031013, 2009080509 2010031074 2011032013, 2009080510 2010032959 2011050980, 2009081004 2010071046 2011060633, 2009090687 2010081821 2011060899, 200909R022 2010101256 2011060900, 2009100222 2010101474 2011060901, 2009100223 2010102203 2011062330, 2009101107 2010110195 2011062331, 2009101690 2010120936 2011062332, 200910C141 2010122183 2011062498, 2009110965 2011010046 201106C035, 2009110966 2011010494 2011080975, 2009121501 2011011473 201108C222, 2010011390 201101C030 2011090562, 2010011391 2011020054 2011090950, 2010011392 2011030367 2011100817, 2010012056 2011032012 2011101452, 2010012921 2011032150 2011101951, 2010020290 2011032151, 2010022274 201103C064, 2010022275 2011050626, 2010022276 2011050630, 2010031071 2011050631, 2010031072 2011060107, 2010031073 2011061424, 201003C015 2011061426, 2010050495 2011062015, 2010050688 2011062030, 2010050805 2011070228, 2010062668 2011070969, 2010072181 2011071094, 2010072183 2011072442, 2010080408 201108C221, 2010080494 2011090018, 2010090239 2011090074, 2010091092 2011100117, 2010091967 2011100643, 2010100152 2011101586, 2010101139 , 2010101140 , 2010110531 , 2010111141 , 2010111142 , 2010120636 , 2011010557 , 2011011652 , 2011020053 , 2011021161 , 2011031034 , 2011031179 , 2011031824, 2011040181, 2011040583, 2011040693, 2011040807, 2011041481.
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 139,777
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 = MEDTRONIC CARDIAC SURGICAL PRODUCTS
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