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

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

  • 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 DLP, DLP Single Stage Venous Cannulae see related information
Date Posted January 18, 2012
Recall Status1 Terminated on May 22, 2014
Recall Number Z-0808-2012
Recall Event ID 60720
510(K)Number K845045 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic DLP, DLP Single Stage Venous Cannulae.

Rx Only, Sterile EO, Nonpyrogenic. Model #'s
66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240, 66136, 66140.

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




























































66132 66134 66136 66140 66236
2008101192 2008101194 2009010875 2008120649 2008101179
2008101193 2008110054 200907R011 2009010329 2008101195
2008110093 2008110425 200909R058 2009010390 2008110325
2008110096 2008110455 2010100002 2009050992 200811C066
2008110414 2008110725 2010100003 200907R013 2008120218
2008110454 2008111013 2010110018 2009090199 2008120650
2008110748 2008111250 2010110395 200909R056 2008120773
2008111009 2008120217 2010121006 2009100211 2009010085
2008111010 2008120648 2010121007 2009110954 2009010330
2008111011 2008120944 2011010047 200912C089 2009010876
2008111012 200812C062 2011010328 2010012823 2009011122
2008120214 2009010328 2011020952 2010020270 2009030771
2008120215 2009010874 201102C050 2010031043 2009031074
2008120216 2009011373 2011030504 2010041078 2009040671
2008120647 2009020833 2010080606 200904R070
2008120942 2009030484 2010101106 2009050647
2008120943 2009030770 2010120623 2009050993
2009010203 2009031073 2010121147 2009051341
2009010327 2009040061 201110R134 2009061235
2009010873 2009040317 2009071056
2009011121 2009040670 2009071384
2009011335 2009041171 200907R033
2009011336 2009050307 2009080480
2009020245 2009050308 2009081942
2009020637 2009050646 2009090678
2009030167 2009050991 2009091610
2009030181 2009051340 200909R043
2009030182 2009060244 2009100212
2009030483 2009060465 2009100551
2009030769 2009060937 2009101090
2009031072 200907R040 2009110262
2009040060 2009080994 2009110263
2009040292 2009081540 2010012824
2009040668 2009081541 2010020271
2009040669 2009081941 2010022234
2009040977 2009090931 2010022235
2009040978 2009090932 2010030374
2009041170 200909R037 2010031044
200904C011 2009100210 2010031045
200904R095 2009101672 2010032276
2009050304 2009110261 2010032950
2009050305 2009112096 201003C170
2009050306 2009120014 2010061605
2009050644 200912C168 2010062291
2009050645 2010012822 2010070158
2009050989 201001C114 2010071047
2009050990 2010020269 2010081684
2009051339 2010022230 2010081820
2009060242 2010022231 201009C072
2009060243 2010022232 2010100686
2009060464 2010022233 2010101382
2009060935 2010030373 2010101395
2009060936 2010031042 2010110198
2009061234 2010032275 2010110644
2009071055 2010032949 2010121562
2009071383 2010040453 2011012069
200907R030 2010050406 201101C084
2009080416 2010050689 2011020885
2009080417 2010051333 201102C069
2009080993 2010060245 2011041302
2009081539 2010060246 2011050254
2009081940 2010070015 2011050454
2009090677 2010070860 2011061103
2009090930 2010071049 2011062712
2009091609 2010071498 2011071488
2009091609 2010090241 2011071705
200909R032 2010091966 2011071706
2009100208 2010092264 2011071792
2009100209 201009C145 2011071875
2009100550 2010102206 201107R008
2009101671 2010102208 201108C070
2009110257 2010102213 2011090564
2009110258 201010C032 2011091136
2009110259 2010110397 2011100264
2009110260 2010110638 2011100534
2009111473 2010110639 2011101478
2009120826 2010120291 2011102136
2009121483 2010120621 201110R007
2010010283 2010120934 2011110012
2010012821 2010121563
201001C016 201012C097
201001C056 2011021513
2010020266 2011021514
2010020267 2011030503
2010020268
2010021559
2010021560
2010021561
2010021562
2010021563
2010021564
2010021565
2010022228
2010022229
2010030372
2010031039
2010031040
2010031041
2010032272
2010032273
2010032274
2010032947
2010032948
201003C120
2010040067
2010041076
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 336,171
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.
-
-