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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

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 Class 2 Device Recall Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip. see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0807-2012
Recall Event ID 60720
510(K)Number K842375 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.

Rx Only, Sterile EO, Nonpyrogenic. Model number #'s :
67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, 69322, 69324, 69328, 69331, 69424, 69428, 69431, 69528, 69531.

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 #


69431 67312 67314 67316
2009010377 2008110555 2008101197 200808C074
2009010733 2008110584 2008101198 2008110082
2009011144 2008110593 2008101199 2008110085
2009030545 2008110627 200810C087 2008110088
200903C053 2008110628 2008110326 2008110227
2009050720 2008110769 2008111018 2008110238
2009051020 2008110932 2008111019 2008110456
2009060260 2008111015 200811C088 2008110457
2009060955 2008111016 2008120221 2008110471
2009070017 2008111017 2008120393 2008111020
2009081561 2008111148 2008120655 2008111270
2009090939 2008111269 2008120946 2008120222
2009101695 2008120219 2008121120 2008120223
2009110293 2008120220 200812C091 2008120656
2010011405 2008120651 200812C235 2008120947
2010012934 2008120652 2009010204 2008121121
2010022294 2008120653 2009010205 2009010334
2010030396 2008120654 2009010332 2009011377
2010031095 2008120945 2009010333 2009020247
2010032967 200812C034 2009011124 2009020248
2010032968 2009010331 2009011375 2009020249
201003C057 2009010878 2009011376 2009030485
2010062163 2009011123 2009020648 2009030776
201007C041 2009011374 2009020834 2009031075
2010081967 2009020246 2009021163 2009031076
2010090957 2009020638 2009030192 2009031077
2010100006 2009021162 2009030193 2009040064
201010C069 2009030250 2009030194 2009040675
2010111455 2009030772 2009030195 2009050705
2010120043 2009030773 2009030251 2009050941
2011020616 2009030774 2009030775 2009050942
2011021651 200903C057 2009040063 2009050998
2011041265 200903R025 2009041173 2009051344
2011051033 200903R030 2009050995 2009060918
2011051682 200903R035 2009050996 2009061499
2011101554 200903R040 2009050997 200906R208
200903R045 2009051342 2009070274
2009040062 2009051343 2009081544
2009040672 2009060245 2009081945
2009040673 2009060246 2009090203
2009040674 2009060470 2009091612
2009041172 2009060472 2009100215
200904C030 2009060473 2009100554
200904C123 2009060939 2009101095
200904R050 2009061237 2009101675
200904R055 2009061238 2009101676
200904R060 200906C002 200910C010
2009050079 200906R207 200910C054
2009050082 2009070534 2009112099
2009050083 2009071386 200911C079
2009050084 200907C086 2010012829
2009050085 2009081543 201001C059
2009050309 2009081944 2010020281
2009050648 2009090202 2010020282
2009050994 2009090681 2010022246
200905C081 2009090933 2010022247
200905C096 200909C002 2010022248
2009061236 200909C034 2010022249
2009061498 200909C092 2010030378
200906R202 2009100214 2010031052
2009071385 2009100553 2010031053
200907C042 2009101094 2010032281
200907R005 2009101674 2010032953
200907R006 200910C145 2010040365
200907R007 2009110265 2010050496
200907R008 2009110956 2010062967
2009080482 2009111477 2010070064
2009080490 2009112098 2010071011
200908C078 2009120830 2010071501
2009090201 200912C087 2010080884
2009090680 2010012828 2010081078
2009091611 201001C058 2010081223
2009100213 2010020277 2010090001
2009100552 2010020278 2010090242
2009101093 2010020279 2010090436
200910C005 2010020280 2010090669
200910C147 2010022242 201009C149
2009110264 2010022243 2010100688
2009110955 2010022244 2010100706
2009111476 2010022245 2010100778
2009120016 2010030376 2010101105
2010012827 2010030377 2010101143
201001C008 2010031051 201010C068
2010020273 2010032279 2010111574
2010020274 2010032280 2010121148
2010020275 2010032952 2010121279
2010020276 2010050407 2010122077
2010022238 2010061488 2011010051
2010022239 2010061491 2011011035
2010022240 2010062707 201101C037
2010022241 2010071007 2011020211
2010030375 2010071008 2011021162
2010031048 2010071150 2011022135
2010031049 2010072017 2011030093
2010031050 2010080082 2011030319
2010032278 2010080976 2011031157
2010032951 2010081079 2011031646
201003C171 2010081526 2011031883
2010040454 2010091335 2011040006
2010040455 2010091509 2011040383
2010061932 2010092142 2011040427
2010062962 201009C101 201
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-526-6000
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 614,382
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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