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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 Device 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
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 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 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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