• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Single Stage Venous Cannula

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Medtronic, Single Stage Venous Cannula see related information
Date Posted January 18, 2012
Recall Status1 Terminated 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 0613551 10526622
11231080 10832391 10631746 10930780 10602851 10521720
11206066 10820593 10602783 10867470 10577109 10468760
11182272 10806904 10593927 10856280 10552240 10460162
11154406 10792651 10584280 10843149 10521701 10420850
11150755 10783531 10577075 10832392 10318761 10370321
11137740 10762628 10566526 10820594 10289594 10360543
11058849 10751521 10503905 10806905 10278841 10318727
11050668 10674164 10494797 10792652 10269112 10261331
11041176 10631765 10479479 10783532 10261334 10224560
11007100 10621311 10397558 10773250 10199614 10175944
10980906 10593951 10395345 10762629 10176023
10960984 10583515 10383009 10613400
10856278 10569669 10380509 10583513
10843210 10559114 10360542 10577110
10832390 10552204 10330246 10569667
10820592 10521705 10339016 10460147
10806903 10503888 10322855 10390319
10783530 10494753 10271119 10370317
10773249 10487834 10175986 10360551
10762627 10479514 10318749
10729512 10468767 10297689
10593914 10460140 10199613
10569680 10443571
10559134 10408590
10542901 10397633
10514237 10395341
10503891 10380514
10487802 10318809
10468761 10318755
10460163 10297693
10443563 10278837
10408593 10191685
10395325
10390317
10383058
10318747
10310127
10176022
10168504







CB66140 CB66236 CB66240 CB67312 CB67314 CB67316
11710278 10856282 10913655 11843701 11799793 11773402
10792653 11773411 11773405 11721260
11150766 10674109 11710239 11749854 11655484
10659949 11641133 11627306 11613156
11173267 11627298 11315477 11599771
11613144 11182266 11572760
11193423 11397357 11114383 11538319
11315465 11069200 11434981
11231092 11058812 11028721 11278703
11050681 11016745 11193478
11278705 11007102 11007103 11150787
10992838 10992839 11091694
11411012 10960985 10980903 11050688
10878784 10970849 11041180
11538331 10832393 10878785 10992840
10691448 10856283 10970850
11627328 10613414 10832394 10960986
10535617 10820596 10878786
11681310 10503871 10792654 10831678
10487783 10773252 10820597
10176010 10479477 10751523 10820598
10460161 10738034 10773253
10232698 10721063 10751525
10542920 10751524
10243466 10526614 10729536
10514238 10652290
10261358 10494790 10593920
10487818 10569675
10278867 10479491 10514250
10468802 10487846
10318724 10460149 10479485
10448672 10468800
10535599 10189494 10460188
10189492 10435591
10542877 10420843
10403807
10569699 10318697
10310119
10593943 10289588
10278865
10613560 10218174
10215035
10621477 10199619

10631755

10643153

10652271

10721064

10738033

10773251

11749857






CB67318 CB67320 CB67512 CB67514 CB67516 CB67518
11799773 10176018 11855547 10297643 11827753 11502624
11773388 11813261 11681280 11154374
11721247 10525864 11799808 10980872 10980877 11137718
11655500 11785633 10691420 10783533
11627302 10536236 10613365 11655464 10297644 10743959
11599778 10593901 10232496
11502625 10542894 11710275 10175992
11326452
11041181 10613552
10992841
10919618 11099826
10888953
10820599 11108114
10593939
10569674 11114403
10542917
10521697 11721238
10479539
10289593
10278876
10269127
10261354
10255194
10243449
10218173
10218172
10185494







































CB67520 CB67522 CB67524 CB67528 CB67530 CB67532
11749837 11773418
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 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 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.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC CARDIAC SURGICAL PRODUCTS
-
-