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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Medtronic DLP, DLP 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-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 2008120644 2009010029 2008111006 2008111008, 2008120392 2009010200 2009010201 2008111024 200811C087, 2008120940 2009010870 2009010871 2008120213 2008120646, 2009010172 2009011118 2009020243 2008120611 2008120941, 2009010325 2009020242 2009021161 2008120645 2008121002, 2009010869 2009021160 2009030249 2009010202 2009011035, 2009011332 2009030248 2009040664 2009010326 2009011120, 200901C065 2009031070 2009050302 2009010872 2009011334, 2009020241 2009050301 2009060462 2009011119 2009020244, 2009020636 2009050986 200907R029 2009011333 2009021155, 2009020852 2009051337 2009081537 2009020832 2009030020, 2009040663 2009060461 200909R020 2009020979 2009040291, 2009041169 2009070460 2009100204 2009030768 2009040667, 2009050300 2009071052 2009111472 2009031071 2009040976, 2009050641 200907R038 2009120824 2009040218 200904R081, 2009051306 2009080412 2010012818 2009040665 2009050303, 2009060240 2009080995 2010020261 2009040666 2009050643, 2009060932 2009081536 2010022573 2009040975 2009050988, 2009061233 200909R034 2010040066 2009050642 2009051338, 2009080411 2009100203 2010050944 2009050987 2009060241, 2009080989 2009101668 2010070858 2009060933 2009060463, 2009080990 200910C012 2010081222 2009061497 2009060934, 2009081535 2009111471 2010090055 2009071053 2009070533, 2009090196 2009121480 2010100151 2009071381 2009071054, 2009090675 2010012817 2010100993 200907R039 2009071382, 2009091606 2010020260 2010101403 2009080413 200907R044, 200909R021 2010022223 2010101613 2009080991 2009080414, 2009101667 2010022224 201011C177 2009090197 2009080415, 2009102292 2010030370 2010120024 2009091607 2009080992, 2009110953 2010031034 2010120622 200909R040 2009081538, 2009111470 2010032944 2011010322 2009100205 200908C100, 2009120573 2010040452 2011011132 2009101088 2009090198, 200912C149 2010051303 2011011938 2009101669 2009090676, 2010012816 2010061607 2009110253 2009090929, 201001C007 2010061907 2009110254 2009091608, 2010020257 2010071740 2009110255 200909C006, 2010020258 2010071741 200911C013 2009100206, 2010020259 2010072134 200911C078 2009100207, 2010022221 2010081641 2009121481 2009100549, 2010022222 2010092650 2009121708 2009101089, 2010030369 2010100996 2010012819 2009101670, 2010031032 2010100997 201001C118 2009102293, 2010031033 2010101947 2010020262 200910C148, 2010032268 201010C067 2010022225 2009110256, 2010050405 2010120014 2010022226 2009120574, 2010051057 2010120935 2010031035 2009120825, 2010061486 2011010928 2010031036 2009121482, 2010061490 2011011088 2010032269 200912C046, 2010072132 2011030441 2010032270 2010012820, 2010080493 2011031456 2010032945 2010020263, 2010081685 201103C141 2010041512 2010020264, 2010091890 2010051329 2010020265, 2010091891 2010061609 2010022227, 201009C029 2010061828 2010030371, 2010100684 2010062608 2010031037, 2010101317 2010062611 2010031038, 2010101318 2010062612 2010032271, 2010101319 2010081220 2010032946, 2010101322 2010081501 2010051328, 2010111730 2010082110 2010060124, 2010111998 2010082230 2010060582, 2010111999 2010082233 2010060854, 201011C098 2010091090 2010060856, 2010120131 2010091508 2010060856, 201012C044 2010100004 2010060856, 2011010134 2010102076 2010061251, 2011020333 2010102077 2010061252, 2011020334 2010102079 2010070159, 2011020338 2010110396 2010070568, 2011020339 2010110637 2010070729, 2011020601 2010110641 2010071048, 2011020603 201011C024 2010080607, 2011020954 2010120013 2010081687, 201102C066 2010120292 2010090238, 2011030501 201012C082 2010090763, 201107R024 2011010755 2010091807, 2011020022 2010092137, 2011020023 2010100988, 2011020951 2010101095, 2011021957 2010101137, 2011030056 2010101479, 2011031173 2010101610, 2011032149 2010110200, 2011032524 2010110642, 201103C022 2010110645, 2010111143, 2010112000, 2010120620, 2010122185, 2011010756, 2011011089, 2011031032, 2011032523, 201103C073, 8*09080415, 8*09080415, , , , ,
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 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 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 = DLP, INC.
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